Eli Lilly RX
FDA Approved Drugs

Eli Lilly RX

FDA Approved Drugs Database

FDA approved drug product records including application numbers, product numbers, drug names, active ingredients, dosage forms, strengths, approval dates and regulatory status.

RX
  • Total Records 76
  • Latest Approval Date Apr 01, 2026
  • Data Source FDA
  • First Approval Date Dec 09, 1997
All
339
View
Unclassified
59
View
Discontinued
204
View
RX
76
View
Company Overview

Company

Eli Lilly RX

Country

U.S.A

Website

Visit Website

Email

info@lilly.com

Social Profiles

LinkedIn X / Twitter
Company Snapshot

Eli Lilly RX

Lilly Corporate Center, Indianapolis, Indiana 46285

U.S.A

www.lilly.com/ info@lilly.com View on Map
FDA Approved Drug Records ( 76 records )
2009
22 May
RX Application: 22332

Drug Name

ADCIRCA

Product Number

1

Dosage Form

-

Strength

20MG

Approval Date

2009-05-22

22332 / 1

Active Ingredient

TADALAFIL

Application Number

22332

Product Number

1

Dosage Form

-

Strength

20MG

Approval Date

2009-05-22

Regulatory Status

RX

2004
04 Feb
RX Application: 21462

Drug Name

ALIMTA

Product Number

1

Dosage Form

-

Strength

EQ 500MG BASE/VIAL

Approval Date

2004-02-04

21462 / 1

Active Ingredient

PEMETREXED DISODIUM

Application Number

21462

Product Number

1

Dosage Form

-

Strength

EQ 500MG BASE/VIAL

Approval Date

2004-02-04

Regulatory Status

RX

2007
07 Sep
RX Application: 21462

Drug Name

ALIMTA

Product Number

2

Dosage Form

-

Strength

EQ 100MG BASE/VIAL

Approval Date

2007-09-07

21462 / 2

Active Ingredient

PEMETREXED DISODIUM

Application Number

21462

Product Number

2

Dosage Form

-

Strength

EQ 100MG BASE/VIAL

Approval Date

2007-09-07

Regulatory Status

RX

2003
21 Nov
RX Application: 21368

Drug Name

CIALIS

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

2003-11-21

21368 / 1

Active Ingredient

TADALAFIL

Application Number

21368

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

2003-11-21

Regulatory Status

RX

2003
21 Nov
RX Application: 21368

Drug Name

CIALIS

Product Number

2

Dosage Form

-

Strength

10MG

Approval Date

2003-11-21

21368 / 2

Active Ingredient

TADALAFIL

Application Number

21368

Product Number

2

Dosage Form

-

Strength

10MG

Approval Date

2003-11-21

Regulatory Status

RX

2003
21 Nov
RX Application: 21368

Drug Name

CIALIS

Product Number

3

Dosage Form

-

Strength

20MG

Approval Date

2003-11-21

21368 / 3

Active Ingredient

TADALAFIL

Application Number

21368

Product Number

3

Dosage Form

-

Strength

20MG

Approval Date

2003-11-21

Regulatory Status

RX

1997
09 Dec
RX Application: 20815

Drug Name

EVISTA

Product Number

1

Dosage Form

-

Strength

60MG

Approval Date

1997-12-09

20815 / 1

Active Ingredient

RALOXIFENE HYDROCHLORIDE

Application Number

20815

Product Number

1

Dosage Form

-

Strength

60MG

Approval Date

1997-12-09

Regulatory Status

RX

2008
25 Jun
RX Application: 21318

Drug Name

FORTEO

Product Number

2

Dosage Form

-

Strength

0.56MG/2.24ML (0.25MG/ML)

Approval Date

2008-06-25

21318 / 2

Active Ingredient

TERIPARATIDE

Application Number

21318

Product Number

2

Dosage Form

-

Strength

0.56MG/2.24ML (0.25MG/ML)

Approval Date

2008-06-25

Regulatory Status

RX

2026
01 Apr
RX Application: 220934

Drug Name

FOUNDAYO

Product Number

1

Dosage Form

-

Strength

EQ 0.8MG BASE

Approval Date

2026-04-01

220934 / 1

Active Ingredient

ORFORGLIPRON CALCIUM

Application Number

220934

Product Number

1

Dosage Form

-

Strength

EQ 0.8MG BASE

Approval Date

2026-04-01

Regulatory Status

RX

2026
01 Apr
RX Application: 220934

Drug Name

FOUNDAYO

Product Number

2

Dosage Form

-

Strength

EQ 2.5MG BASE

Approval Date

2026-04-01

220934 / 2

Active Ingredient

ORFORGLIPRON CALCIUM

Application Number

220934

Product Number

2

Dosage Form

-

Strength

EQ 2.5MG BASE

Approval Date

2026-04-01

Regulatory Status

RX

2026
01 Apr
RX Application: 220934

Drug Name

FOUNDAYO

Product Number

3

Dosage Form

-

Strength

EQ 5.5MG BASE

Approval Date

2026-04-01

220934 / 3

Active Ingredient

ORFORGLIPRON CALCIUM

Application Number

220934

Product Number

3

Dosage Form

-

Strength

EQ 5.5MG BASE

Approval Date

2026-04-01

Regulatory Status

RX

2026
01 Apr
RX Application: 220934

Drug Name

FOUNDAYO

Product Number

4

Dosage Form

-

Strength

EQ 9MG BASE

Approval Date

2026-04-01

220934 / 4

Active Ingredient

ORFORGLIPRON CALCIUM

Application Number

220934

Product Number

4

Dosage Form

-

Strength

EQ 9MG BASE

Approval Date

2026-04-01

Regulatory Status

RX

2026
01 Apr
RX Application: 220934

Drug Name

FOUNDAYO

Product Number

5

Dosage Form

-

Strength

EQ 14.5MG BASE

Approval Date

2026-04-01

220934 / 5

Active Ingredient

ORFORGLIPRON CALCIUM

Application Number

220934

Product Number

5

Dosage Form

-

Strength

EQ 14.5MG BASE

Approval Date

2026-04-01

Regulatory Status

RX

2026
01 Apr
RX Application: 220934

Drug Name

FOUNDAYO

Product Number

6

Dosage Form

-

Strength

EQ 17.2MG BASE

Approval Date

2026-04-01

220934 / 6

Active Ingredient

ORFORGLIPRON CALCIUM

Application Number

220934

Product Number

6

Dosage Form

-

Strength

EQ 17.2MG BASE

Approval Date

2026-04-01

Regulatory Status

RX

2025
25 Sep
RX Application: 218881

Drug Name

INLURIYO

Product Number

1

Dosage Form

-

Strength

EQ 200MG BASE

Approval Date

2025-09-25

218881 / 1

Active Ingredient

IMLUNESTRANT TOSYLATE

Application Number

218881

Product Number

1

Dosage Form

-

Strength

EQ 200MG BASE

Approval Date

2025-09-25

Regulatory Status

RX

2023
28 Jul
RX Application: 215866

Drug Name

MOUNJARO

Product Number

7

Dosage Form

-

Strength

2.5MG/0.5ML (2.5MG/0.5ML)

Approval Date

2023-07-28

215866 / 7

Active Ingredient

TIRZEPATIDE

Application Number

215866

Product Number

7

Dosage Form

-

Strength

2.5MG/0.5ML (2.5MG/0.5ML)

Approval Date

2023-07-28

Regulatory Status

RX

2023
28 Jul
RX Application: 215866

Drug Name

MOUNJARO

Product Number

8

Dosage Form

-

Strength

5MG/0.5ML (5MG/0.5ML)

Approval Date

2023-07-28

215866 / 8

Active Ingredient

TIRZEPATIDE

Application Number

215866

Product Number

8

Dosage Form

-

Strength

5MG/0.5ML (5MG/0.5ML)

Approval Date

2023-07-28

Regulatory Status

RX

2023
28 Jul
RX Application: 215866

Drug Name

MOUNJARO

Product Number

9

Dosage Form

-

Strength

7.5MG/0.5ML (7.5MG/0.5ML)

Approval Date

2023-07-28

215866 / 9

Active Ingredient

TIRZEPATIDE

Application Number

215866

Product Number

9

Dosage Form

-

Strength

7.5MG/0.5ML (7.5MG/0.5ML)

Approval Date

2023-07-28

Regulatory Status

RX

2023
28 Jul
RX Application: 215866

Drug Name

MOUNJARO

Product Number

10

Dosage Form

-

Strength

10MG/0.5ML (10MG/0.5ML)

Approval Date

2023-07-28

215866 / 10

Active Ingredient

TIRZEPATIDE

Application Number

215866

Product Number

10

Dosage Form

-

Strength

10MG/0.5ML (10MG/0.5ML)

Approval Date

2023-07-28

Regulatory Status

RX

2023
28 Jul
RX Application: 215866

Drug Name

MOUNJARO

Product Number

11

Dosage Form

-

Strength

12.5MG/0.5ML (12.5MG/0.5ML)

Approval Date

2023-07-28

215866 / 11

Active Ingredient

TIRZEPATIDE

Application Number

215866

Product Number

11

Dosage Form

-

Strength

12.5MG/0.5ML (12.5MG/0.5ML)

Approval Date

2023-07-28

Regulatory Status

RX

2023
28 Jul
RX Application: 215866

Drug Name

MOUNJARO

Product Number

12

Dosage Form

-

Strength

15MG/0.5ML (15MG/0.5ML)

Approval Date

2023-07-28

215866 / 12

Active Ingredient

TIRZEPATIDE

Application Number

215866

Product Number

12

Dosage Form

-

Strength

15MG/0.5ML (15MG/0.5ML)

Approval Date

2023-07-28

Regulatory Status

RX

2026
07 Jan
RX Application: 215866

Drug Name

MOUNJARO

Product Number

13

Dosage Form

-

Strength

10MG/2.4ML (4.17MG/ML)

Approval Date

2026-01-07

215866 / 13

Active Ingredient

TIRZEPATIDE

Application Number

215866

Product Number

13

Dosage Form

-

Strength

10MG/2.4ML (4.17MG/ML)

Approval Date

2026-01-07

Regulatory Status

RX

2026
07 Jan
RX Application: 215866

Drug Name

MOUNJARO

Product Number

14

Dosage Form

-

Strength

20MG/2.4ML (8.33MG/ML)

Approval Date

2026-01-07

215866 / 14

Active Ingredient

TIRZEPATIDE

Application Number

215866

Product Number

14

Dosage Form

-

Strength

20MG/2.4ML (8.33MG/ML)

Approval Date

2026-01-07

Regulatory Status

RX

2026
07 Jan
RX Application: 215866

Drug Name

MOUNJARO

Product Number

15

Dosage Form

-

Strength

30MG/2.4ML (12.5MG/ML)

Approval Date

2026-01-07

215866 / 15

Active Ingredient

TIRZEPATIDE

Application Number

215866

Product Number

15

Dosage Form

-

Strength

30MG/2.4ML (12.5MG/ML)

Approval Date

2026-01-07

Regulatory Status

RX

2026
07 Jan
RX Application: 215866

Drug Name

MOUNJARO

Product Number

16

Dosage Form

-

Strength

40MG/2.4ML (16.7MG/ML)

Approval Date

2026-01-07

215866 / 16

Active Ingredient

TIRZEPATIDE

Application Number

215866

Product Number

16

Dosage Form

-

Strength

40MG/2.4ML (16.7MG/ML)

Approval Date

2026-01-07

Regulatory Status

RX

2026
07 Jan
RX Application: 215866

Drug Name

MOUNJARO

Product Number

17

Dosage Form

-

Strength

50MG/2.4ML (20.8MG/ML)

Approval Date

2026-01-07

215866 / 17

Active Ingredient

TIRZEPATIDE

Application Number

215866

Product Number

17

Dosage Form

-

Strength

50MG/2.4ML (20.8MG/ML)

Approval Date

2026-01-07

Regulatory Status

RX

2026
07 Jan
RX Application: 215866

Drug Name

MOUNJARO

Product Number

18

Dosage Form

-

Strength

60MG/2.4ML (25MG/ML)

Approval Date

2026-01-07

215866 / 18

Active Ingredient

TIRZEPATIDE

Application Number

215866

Product Number

18

Dosage Form

-

Strength

60MG/2.4ML (25MG/ML)

Approval Date

2026-01-07

Regulatory Status

RX

2022
13 May
RX Application: 215866

Drug Name

MOUNJARO (AUTOINJECTOR)

Product Number

1

Dosage Form

-

Strength

2.5MG/0.5ML (2.5MG/0.5ML)

Approval Date

2022-05-13

215866 / 1

Active Ingredient

TIRZEPATIDE

Application Number

215866

Product Number

1

Dosage Form

-

Strength

2.5MG/0.5ML (2.5MG/0.5ML)

Approval Date

2022-05-13

Regulatory Status

RX

2022
13 May
RX Application: 215866

Drug Name

MOUNJARO (AUTOINJECTOR)

Product Number

2

Dosage Form

-

Strength

5MG/0.5ML (5MG/0.5ML)

Approval Date

2022-05-13

215866 / 2

Active Ingredient

TIRZEPATIDE

Application Number

215866

Product Number

2

Dosage Form

-

Strength

5MG/0.5ML (5MG/0.5ML)

Approval Date

2022-05-13

Regulatory Status

RX

2022
13 May
RX Application: 215866

Drug Name

MOUNJARO (AUTOINJECTOR)

Product Number

3

Dosage Form

-

Strength

7.5MG/0.5ML (7.5MG/0.5ML)

Approval Date

2022-05-13

215866 / 3

Active Ingredient

TIRZEPATIDE

Application Number

215866

Product Number

3

Dosage Form

-

Strength

7.5MG/0.5ML (7.5MG/0.5ML)

Approval Date

2022-05-13

Regulatory Status

RX

2022
13 May
RX Application: 215866

Drug Name

MOUNJARO (AUTOINJECTOR)

Product Number

4

Dosage Form

-

Strength

10MG/0.5ML (10MG/0.5ML)

Approval Date

2022-05-13

215866 / 4

Active Ingredient

TIRZEPATIDE

Application Number

215866

Product Number

4

Dosage Form

-

Strength

10MG/0.5ML (10MG/0.5ML)

Approval Date

2022-05-13

Regulatory Status

RX

2022
13 May
RX Application: 215866

Drug Name

MOUNJARO (AUTOINJECTOR)

Product Number

5

Dosage Form

-

Strength

12.5MG/0.5ML (12.5MG/0.5ML)

Approval Date

2022-05-13

215866 / 5

Active Ingredient

TIRZEPATIDE

Application Number

215866

Product Number

5

Dosage Form

-

Strength

12.5MG/0.5ML (12.5MG/0.5ML)

Approval Date

2022-05-13

Regulatory Status

RX

2022
13 May
RX Application: 215866

Drug Name

MOUNJARO (AUTOINJECTOR)

Product Number

6

Dosage Form

-

Strength

15MG/0.5ML (15MG/0.5ML)

Approval Date

2022-05-13

215866 / 6

Active Ingredient

TIRZEPATIDE

Application Number

215866

Product Number

6

Dosage Form

-

Strength

15MG/0.5ML (15MG/0.5ML)

Approval Date

2022-05-13

Regulatory Status

RX

2026
20 Jan
RX Application: 215866

Drug Name

MOUNJARO KWIKPEN

Product Number

19

Dosage Form

-

Strength

10MG/2.4ML (4.17MG/ML)

Approval Date

2026-01-20

215866 / 19

Active Ingredient

TIRZEPATIDE

Application Number

215866

Product Number

19

Dosage Form

-

Strength

10MG/2.4ML (4.17MG/ML)

Approval Date

2026-01-20

Regulatory Status

RX

2026
20 Jan
RX Application: 215866

Drug Name

MOUNJARO KWIKPEN

Product Number

20

Dosage Form

-

Strength

20MG/2.4ML (8.33MG/ML)

Approval Date

2026-01-20

215866 / 20

Active Ingredient

TIRZEPATIDE

Application Number

215866

Product Number

20

Dosage Form

-

Strength

20MG/2.4ML (8.33MG/ML)

Approval Date

2026-01-20

Regulatory Status

RX

2026
20 Jan
RX Application: 215866

Drug Name

MOUNJARO KWIKPEN

Product Number

21

Dosage Form

-

Strength

30MG/2.4ML (12.5MG/ML)

Approval Date

2026-01-20

215866 / 21

Active Ingredient

TIRZEPATIDE

Application Number

215866

Product Number

21

Dosage Form

-

Strength

30MG/2.4ML (12.5MG/ML)

Approval Date

2026-01-20

Regulatory Status

RX

2026
20 Jan
RX Application: 215866

Drug Name

MOUNJARO KWIKPEN

Product Number

22

Dosage Form

-

Strength

40MG/2.4ML (16.7MG/ML)

Approval Date

2026-01-20

215866 / 22

Active Ingredient

TIRZEPATIDE

Application Number

215866

Product Number

22

Dosage Form

-

Strength

40MG/2.4ML (16.7MG/ML)

Approval Date

2026-01-20

Regulatory Status

RX

2026
20 Jan
RX Application: 215866

Drug Name

MOUNJARO KWIKPEN

Product Number

23

Dosage Form

-

Strength

50MG/2.4ML (20.8MG/ML)

Approval Date

2026-01-20

215866 / 23

Active Ingredient

TIRZEPATIDE

Application Number

215866

Product Number

23

Dosage Form

-

Strength

50MG/2.4ML (20.8MG/ML)

Approval Date

2026-01-20

Regulatory Status

RX

2026
20 Jan
RX Application: 215866

Drug Name

MOUNJARO KWIKPEN

Product Number

24

Dosage Form

-

Strength

60MG/2.4ML (25MG/ML)

Approval Date

2026-01-20

215866 / 24

Active Ingredient

TIRZEPATIDE

Application Number

215866

Product Number

24

Dosage Form

-

Strength

60MG/2.4ML (25MG/ML)

Approval Date

2026-01-20

Regulatory Status

RX

2018
31 May
RX Application: 207924

Drug Name

OLUMIANT

Product Number

1

Dosage Form

-

Strength

2MG

Approval Date

2018-05-31

207924 / 1

Active Ingredient

BARICITINIB

Application Number

207924

Product Number

1

Dosage Form

-

Strength

2MG

Approval Date

2018-05-31

Regulatory Status

RX

2019
08 Oct
RX Application: 207924

Drug Name

OLUMIANT

Product Number

2

Dosage Form

-

Strength

1MG

Approval Date

2019-10-08

207924 / 2

Active Ingredient

BARICITINIB

Application Number

207924

Product Number

2

Dosage Form

-

Strength

1MG

Approval Date

2019-10-08

Regulatory Status

RX

2022
10 May
RX Application: 207924

Drug Name

OLUMIANT

Product Number

3

Dosage Form

-

Strength

4MG

Approval Date

2022-05-10

207924 / 3

Active Ingredient

BARICITINIB

Application Number

207924

Product Number

3

Dosage Form

-

Strength

4MG

Approval Date

2022-05-10

Regulatory Status

RX

2020
08 May
RX Application: 213246

Drug Name

RETEVMO

Product Number

1

Dosage Form

-

Strength

40MG

Approval Date

2020-05-08

213246 / 1

Active Ingredient

SELPERCATINIB

Application Number

213246

Product Number

1

Dosage Form

-

Strength

40MG

Approval Date

2020-05-08

Regulatory Status

RX

2020
08 May
RX Application: 213246

Drug Name

RETEVMO

Product Number

2

Dosage Form

-

Strength

80MG

Approval Date

2020-05-08

213246 / 2

Active Ingredient

SELPERCATINIB

Application Number

213246

Product Number

2

Dosage Form

-

Strength

80MG

Approval Date

2020-05-08

Regulatory Status

RX

2024
10 Apr
RX Application: 218160

Drug Name

RETEVMO

Product Number

1

Dosage Form

-

Strength

40MG

Approval Date

2024-04-10

218160 / 1

Active Ingredient

SELPERCATINIB

Application Number

218160

Product Number

1

Dosage Form

-

Strength

40MG

Approval Date

2024-04-10

Regulatory Status

RX

2024
10 Apr
RX Application: 218160

Drug Name

RETEVMO

Product Number

2

Dosage Form

-

Strength

80MG

Approval Date

2024-04-10

218160 / 2

Active Ingredient

SELPERCATINIB

Application Number

218160

Product Number

2

Dosage Form

-

Strength

80MG

Approval Date

2024-04-10

Regulatory Status

RX

2024
10 Apr
RX Application: 218160

Drug Name

RETEVMO

Product Number

3

Dosage Form

-

Strength

120MG

Approval Date

2024-04-10

218160 / 3

Active Ingredient

SELPERCATINIB

Application Number

218160

Product Number

3

Dosage Form

-

Strength

120MG

Approval Date

2024-04-10

Regulatory Status

RX

2024
10 Apr
RX Application: 218160

Drug Name

RETEVMO

Product Number

4

Dosage Form

-

Strength

160MG

Approval Date

2024-04-10

218160 / 4

Active Ingredient

SELPERCATINIB

Application Number

218160

Product Number

4

Dosage Form

-

Strength

160MG

Approval Date

2024-04-10

Regulatory Status

RX

2017
28 Sep
RX Application: 208716

Drug Name

VERZENIO

Product Number

1

Dosage Form

-

Strength

50MG

Approval Date

2017-09-28

208716 / 1

Active Ingredient

ABEMACICLIB

Application Number

208716

Product Number

1

Dosage Form

-

Strength

50MG

Approval Date

2017-09-28

Regulatory Status

RX

2017
28 Sep
RX Application: 208716

Drug Name

VERZENIO

Product Number

2

Dosage Form

-

Strength

100MG

Approval Date

2017-09-28

208716 / 2

Active Ingredient

ABEMACICLIB

Application Number

208716

Product Number

2

Dosage Form

-

Strength

100MG

Approval Date

2017-09-28

Regulatory Status

RX

2017
28 Sep
RX Application: 208716

Drug Name

VERZENIO

Product Number

3

Dosage Form

-

Strength

150MG

Approval Date

2017-09-28

208716 / 3

Active Ingredient

ABEMACICLIB

Application Number

208716

Product Number

3

Dosage Form

-

Strength

150MG

Approval Date

2017-09-28

Regulatory Status

RX

2017
28 Sep
RX Application: 208716

Drug Name

VERZENIO

Product Number

4

Dosage Form

-

Strength

200MG

Approval Date

2017-09-28

208716 / 4

Active Ingredient

ABEMACICLIB

Application Number

208716

Product Number

4

Dosage Form

-

Strength

200MG

Approval Date

2017-09-28

Regulatory Status

RX

2024
28 Mar
RX Application: 217806

Drug Name

ZEPBOUND

Product Number

7

Dosage Form

-

Strength

2.5MG/0.5ML (2.5MG/0.5ML)

Approval Date

2024-03-28

217806 / 7

Active Ingredient

TIRZEPATIDE

Application Number

217806

Product Number

7

Dosage Form

-

Strength

2.5MG/0.5ML (2.5MG/0.5ML)

Approval Date

2024-03-28

Regulatory Status

RX

2024
28 Mar
RX Application: 217806

Drug Name

ZEPBOUND

Product Number

8

Dosage Form

-

Strength

5MG/0.5ML (5MG/0.5ML)

Approval Date

2024-03-28

217806 / 8

Active Ingredient

TIRZEPATIDE

Application Number

217806

Product Number

8

Dosage Form

-

Strength

5MG/0.5ML (5MG/0.5ML)

Approval Date

2024-03-28

Regulatory Status

RX

2024
28 Mar
RX Application: 217806

Drug Name

ZEPBOUND

Product Number

9

Dosage Form

-

Strength

7.5MG/0.5ML (7.5MG/0.5ML)

Approval Date

2024-03-28

217806 / 9

Active Ingredient

TIRZEPATIDE

Application Number

217806

Product Number

9

Dosage Form

-

Strength

7.5MG/0.5ML (7.5MG/0.5ML)

Approval Date

2024-03-28

Regulatory Status

RX

2024
28 Mar
RX Application: 217806

Drug Name

ZEPBOUND

Product Number

10

Dosage Form

-

Strength

10MG/0.5ML (10MG/0.5ML)

Approval Date

2024-03-28

217806 / 10

Active Ingredient

TIRZEPATIDE

Application Number

217806

Product Number

10

Dosage Form

-

Strength

10MG/0.5ML (10MG/0.5ML)

Approval Date

2024-03-28

Regulatory Status

RX

2024
28 Mar
RX Application: 217806

Drug Name

ZEPBOUND

Product Number

11

Dosage Form

-

Strength

12.5MG/0.5ML (12.5MG/0.5ML)

Approval Date

2024-03-28

217806 / 11

Active Ingredient

TIRZEPATIDE

Application Number

217806

Product Number

11

Dosage Form

-

Strength

12.5MG/0.5ML (12.5MG/0.5ML)

Approval Date

2024-03-28

Regulatory Status

RX

2024
28 Mar
RX Application: 217806

Drug Name

ZEPBOUND

Product Number

12

Dosage Form

-

Strength

15MG/0.5ML (15MG/0.5ML)

Approval Date

2024-03-28

217806 / 12

Active Ingredient

TIRZEPATIDE

Application Number

217806

Product Number

12

Dosage Form

-

Strength

15MG/0.5ML (15MG/0.5ML)

Approval Date

2024-03-28

Regulatory Status

RX

2026
07 Jan
RX Application: 217806

Drug Name

ZEPBOUND

Product Number

13

Dosage Form

-

Strength

10MG/2.4ML (4.17MG/ML)

Approval Date

2026-01-07

217806 / 13

Active Ingredient

TIRZEPATIDE

Application Number

217806

Product Number

13

Dosage Form

-

Strength

10MG/2.4ML (4.17MG/ML)

Approval Date

2026-01-07

Regulatory Status

RX

2026
07 Jan
RX Application: 217806

Drug Name

ZEPBOUND

Product Number

14

Dosage Form

-

Strength

20MG/2.4ML (8.33MG/ML)

Approval Date

2026-01-07

217806 / 14

Active Ingredient

TIRZEPATIDE

Application Number

217806

Product Number

14

Dosage Form

-

Strength

20MG/2.4ML (8.33MG/ML)

Approval Date

2026-01-07

Regulatory Status

RX

2026
07 Jan
RX Application: 217806

Drug Name

ZEPBOUND

Product Number

15

Dosage Form

-

Strength

30MG/2.4ML (12.5MG/ML)

Approval Date

2026-01-07

217806 / 15

Active Ingredient

TIRZEPATIDE

Application Number

217806

Product Number

15

Dosage Form

-

Strength

30MG/2.4ML (12.5MG/ML)

Approval Date

2026-01-07

Regulatory Status

RX

2026
07 Jan
RX Application: 217806

Drug Name

ZEPBOUND

Product Number

16

Dosage Form

-

Strength

40MG/2.4ML (16.7MG/ML)

Approval Date

2026-01-07

217806 / 16

Active Ingredient

TIRZEPATIDE

Application Number

217806

Product Number

16

Dosage Form

-

Strength

40MG/2.4ML (16.7MG/ML)

Approval Date

2026-01-07

Regulatory Status

RX

2026
07 Jan
RX Application: 217806

Drug Name

ZEPBOUND

Product Number

17

Dosage Form

-

Strength

50MG/2.4ML (20.8MG/ML)

Approval Date

2026-01-07

217806 / 17

Active Ingredient

TIRZEPATIDE

Application Number

217806

Product Number

17

Dosage Form

-

Strength

50MG/2.4ML (20.8MG/ML)

Approval Date

2026-01-07

Regulatory Status

RX

2026
07 Jan
RX Application: 217806

Drug Name

ZEPBOUND

Product Number

18

Dosage Form

-

Strength

60MG/2.4ML (25MG/ML)

Approval Date

2026-01-07

217806 / 18

Active Ingredient

TIRZEPATIDE

Application Number

217806

Product Number

18

Dosage Form

-

Strength

60MG/2.4ML (25MG/ML)

Approval Date

2026-01-07

Regulatory Status

RX

2023
08 Nov
RX Application: 217806

Drug Name

ZEPBOUND (AUTOINJECTOR)

Product Number

1

Dosage Form

-

Strength

2.5MG/0.5ML (2.5MG/0.5ML)

Approval Date

2023-11-08

217806 / 1

Active Ingredient

TIRZEPATIDE

Application Number

217806

Product Number

1

Dosage Form

-

Strength

2.5MG/0.5ML (2.5MG/0.5ML)

Approval Date

2023-11-08

Regulatory Status

RX

2023
08 Nov
RX Application: 217806

Drug Name

ZEPBOUND (AUTOINJECTOR)

Product Number

2

Dosage Form

-

Strength

5MG/0.5ML (5MG/0.5ML)

Approval Date

2023-11-08

217806 / 2

Active Ingredient

TIRZEPATIDE

Application Number

217806

Product Number

2

Dosage Form

-

Strength

5MG/0.5ML (5MG/0.5ML)

Approval Date

2023-11-08

Regulatory Status

RX

2023
08 Nov
RX Application: 217806

Drug Name

ZEPBOUND (AUTOINJECTOR)

Product Number

3

Dosage Form

-

Strength

7.5MG/0.5ML (7.5MG/0.5ML)

Approval Date

2023-11-08

217806 / 3

Active Ingredient

TIRZEPATIDE

Application Number

217806

Product Number

3

Dosage Form

-

Strength

7.5MG/0.5ML (7.5MG/0.5ML)

Approval Date

2023-11-08

Regulatory Status

RX

2023
08 Nov
RX Application: 217806

Drug Name

ZEPBOUND (AUTOINJECTOR)

Product Number

4

Dosage Form

-

Strength

10MG/0.5ML (10MG/0.5ML)

Approval Date

2023-11-08

217806 / 4

Active Ingredient

TIRZEPATIDE

Application Number

217806

Product Number

4

Dosage Form

-

Strength

10MG/0.5ML (10MG/0.5ML)

Approval Date

2023-11-08

Regulatory Status

RX

2023
08 Nov
RX Application: 217806

Drug Name

ZEPBOUND (AUTOINJECTOR)

Product Number

5

Dosage Form

-

Strength

12.5MG/0.5ML (12.5MG/0.5ML)

Approval Date

2023-11-08

217806 / 5

Active Ingredient

TIRZEPATIDE

Application Number

217806

Product Number

5

Dosage Form

-

Strength

12.5MG/0.5ML (12.5MG/0.5ML)

Approval Date

2023-11-08

Regulatory Status

RX

2023
08 Nov
RX Application: 217806

Drug Name

ZEPBOUND (AUTOINJECTOR)

Product Number

6

Dosage Form

-

Strength

15MG/0.5ML (15MG/0.5ML)

Approval Date

2023-11-08

217806 / 6

Active Ingredient

TIRZEPATIDE

Application Number

217806

Product Number

6

Dosage Form

-

Strength

15MG/0.5ML (15MG/0.5ML)

Approval Date

2023-11-08

Regulatory Status

RX

2026
20 Jan
RX Application: 217806

Drug Name

ZEPBOUND KWIKPEN

Product Number

19

Dosage Form

-

Strength

10MG/2.4ML (4.17MG/ML)

Approval Date

2026-01-20

217806 / 19

Active Ingredient

TIRZEPATIDE

Application Number

217806

Product Number

19

Dosage Form

-

Strength

10MG/2.4ML (4.17MG/ML)

Approval Date

2026-01-20

Regulatory Status

RX

2026
20 Jan
RX Application: 217806

Drug Name

ZEPBOUND KWIKPEN

Product Number

20

Dosage Form

-

Strength

20MG/2.4ML (8.33MG/ML)

Approval Date

2026-01-20

217806 / 20

Active Ingredient

TIRZEPATIDE

Application Number

217806

Product Number

20

Dosage Form

-

Strength

20MG/2.4ML (8.33MG/ML)

Approval Date

2026-01-20

Regulatory Status

RX

2026
20 Jan
RX Application: 217806

Drug Name

ZEPBOUND KWIKPEN

Product Number

21

Dosage Form

-

Strength

30MG/2.4ML (12.5MG/ML)

Approval Date

2026-01-20

217806 / 21

Active Ingredient

TIRZEPATIDE

Application Number

217806

Product Number

21

Dosage Form

-

Strength

30MG/2.4ML (12.5MG/ML)

Approval Date

2026-01-20

Regulatory Status

RX

2026
20 Jan
RX Application: 217806

Drug Name

ZEPBOUND KWIKPEN

Product Number

22

Dosage Form

-

Strength

40MG/2.4ML (16.7MG/ML)

Approval Date

2026-01-20

217806 / 22

Active Ingredient

TIRZEPATIDE

Application Number

217806

Product Number

22

Dosage Form

-

Strength

40MG/2.4ML (16.7MG/ML)

Approval Date

2026-01-20

Regulatory Status

RX

2026
20 Jan
RX Application: 217806

Drug Name

ZEPBOUND KWIKPEN

Product Number

23

Dosage Form

-

Strength

50MG/2.4ML (20.8MG/ML)

Approval Date

2026-01-20

217806 / 23

Active Ingredient

TIRZEPATIDE

Application Number

217806

Product Number

23

Dosage Form

-

Strength

50MG/2.4ML (20.8MG/ML)

Approval Date

2026-01-20

Regulatory Status

RX

2026
20 Jan
RX Application: 217806

Drug Name

ZEPBOUND KWIKPEN

Product Number

24

Dosage Form

-

Strength

60MG/2.4ML (25MG/ML)

Approval Date

2026-01-20

217806 / 24

Active Ingredient

TIRZEPATIDE

Application Number

217806

Product Number

24

Dosage Form

-

Strength

60MG/2.4ML (25MG/ML)

Approval Date

2026-01-20

Regulatory Status

RX

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Drug Status Breakdown
76 total
  • RX
Official Source

FDA approved drug data is based on publicly available U.S. Food and Drug Administration Orange Book information.

Visit FDA Orange Book
FDA Approved Drug Record Details Preview

Explore important FDA approved drug information available in the records above.

Drug Name

ADCIRCA

Application Number

22332

Product Number

1

Active Ingredient

TADALAFIL

Dosage Form

-

Strength

20MG

FDA Approved Drug Data

Approved drug product information

Regular Updates

Data maintained from official sources

Structured Database

Searchable pharmaceutical data

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Organized FDA drug records

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