TerSera Therapeutics
FDA Approved Drugs

TerSera Therapeutics

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.

Discontinued RX
  • Total Records 7
  • Latest Approval Date Oct 19, 2018
  • Data Source FDA
  • First Approval Date Dec 29, 1989
All
7
View
Discontinued
3
View
RX
4
View
Company Overview

Company

TerSera Therapeutics

Country

U.S.A

Social Profiles

Company Snapshot

TerSera Therapeutics

520 Lake Cook Rd, Suite 500, Deerfield, Illinois 60015

U.S.A

www.tersera.com/ medicalinformation@tersera.com View on Map
FDA Approved Drug Records ( 7 records )
2018
19 Oct
Discontinued Application: 211210

Drug Name

QMIIZ ODT

Product Number

1

Dosage Form

-

Strength

7.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

2018-10-19

211210 / 1

Active Ingredient

MELOXICAM

Application Number

211210

Product Number

1

Dosage Form

-

Strength

7.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

2018-10-19

Regulatory Status

Discontinued

2018
19 Oct
Discontinued Application: 211210

Drug Name

QMIIZ ODT

Product Number

2

Dosage Form

-

Strength

15MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

2018-10-19

211210 / 2

Active Ingredient

MELOXICAM

Application Number

211210

Product Number

2

Dosage Form

-

Strength

15MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

2018-10-19

Regulatory Status

Discontinued

2015
01 Sep
RX Application: 206500

Drug Name

VARUBI

Product Number

1

Dosage Form

-

Strength

EQ 90MG BASE

Approval Date

2015-09-01

206500 / 1

Active Ingredient

ROLAPITANT HYDROCHLORIDE

Application Number

206500

Product Number

1

Dosage Form

-

Strength

EQ 90MG BASE

Approval Date

2015-09-01

Regulatory Status

RX

2017
25 Oct
Discontinued Application: 208399

Drug Name

VARUBI

Product Number

1

Dosage Form

-

Strength

EQ 166.5MG BASE/92.5ML (EQ 1.8MG BASE/ML)

Approval Date

2017-10-25

208399 / 1

Active Ingredient

ROLAPITANT HYDROCHLORIDE

Application Number

208399

Product Number

1

Dosage Form

-

Strength

EQ 166.5MG BASE/92.5ML (EQ 1.8MG BASE/ML)

Approval Date

2017-10-25

Regulatory Status

Discontinued

2017
28 Feb
RX Application: 208794

Drug Name

XERMELO

Product Number

1

Dosage Form

-

Strength

EQ 250MG BASE

Approval Date

2017-02-28

208794 / 1

Active Ingredient

TELOTRISTAT ETIPRATE

Application Number

208794

Product Number

1

Dosage Form

-

Strength

EQ 250MG BASE

Approval Date

2017-02-28

Regulatory Status

RX

1989
29 Dec
RX Application: 19726

Drug Name

ZOLADEX

Product Number

1

Dosage Form

-

Strength

EQ 3.6MG BASE

Approval Date

1989-12-29

19726 / 1

Active Ingredient

GOSERELIN ACETATE

Application Number

19726

Product Number

1

Dosage Form

-

Strength

EQ 3.6MG BASE

Approval Date

1989-12-29

Regulatory Status

RX

1996
11 Jan
RX Application: 20578

Drug Name

ZOLADEX

Product Number

1

Dosage Form

-

Strength

EQ 10.8MG BASE

Approval Date

1996-01-11

20578 / 1

Active Ingredient

GOSERELIN ACETATE

Application Number

20578

Product Number

1

Dosage Form

-

Strength

EQ 10.8MG BASE

Approval Date

1996-01-11

Regulatory Status

RX

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Drug Status Breakdown
7 total
  • Discontinued
  • RX
Official Source

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

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FDA Approved Drug Record Details Preview

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

Drug Name

QMIIZ ODT

Application Number

211210

Product Number

1

Active Ingredient

MELOXICAM

Dosage Form

-

Strength

7.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

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