SEPTODONT INC RX
FDA Approved Drugs

SEPTODONT INC 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 13
  • Latest Approval Date Mar 19, 2026
  • Data Source FDA
  • First Approval Date Oct 10, 1984
All
19
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Unclassified
1
View
Discontinued
5
View
RX
13
View
Company Overview

Company

SEPTODONT INC RX

Country

U.S.A

Website

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Company Snapshot

SEPTODONT INC RX

205 Granite Run Drive Suite 150 - Lancaster PA. 17601

U.S.A

www.septodontusa.com/ View on Map
FDA Approved Drug Records ( 13 records )
2018
20 Nov
RX Application: 200480

Drug Name

DYCLOPRO

Product Number

1

Dosage Form

-

Strength

0.5%

Approval Date

2018-11-20

200480 / 1

Active Ingredient

DYCLONINE HYDROCHLORIDE

Application Number

200480

Product Number

1

Dosage Form

-

Strength

0.5%

Approval Date

2018-11-20

Regulatory Status

RX

2018
20 Nov
RX Application: 200480

Drug Name

DYCLOPRO

Product Number

2

Dosage Form

-

Strength

1%

Approval Date

2018-11-20

200480 / 2

Active Ingredient

DYCLONINE HYDROCHLORIDE

Application Number

200480

Product Number

2

Dosage Form

-

Strength

1%

Approval Date

2018-11-20

Regulatory Status

RX

2026
19 Mar
RX Application: 216564

Drug Name

FLAVALTA

Product Number

1

Dosage Form

-

Strength

EQ 0.017MG BASE/1.7ML (EQ 0.01MG BASE/ML);34MG/1.7ML (20MG/ML)

Approval Date

2026-03-19

216564 / 1

Active Ingredient

EPINEPHRINE BITARTRATE; LIDOCAINE HYDROCHLORIDE

Application Number

216564

Product Number

1

Dosage Form

-

Strength

EQ 0.017MG BASE/1.7ML (EQ 0.01MG BASE/ML);34MG/1.7ML (20MG/ML)

Approval Date

2026-03-19

Regulatory Status

RX

2011
23 May
RX Application: 40911

Drug Name

LIDOCAINE

Product Number

1

Dosage Form

-

Strength

5%

Approval Date

2011-05-23

40911 / 1

Active Ingredient

LIDOCAINE

Application Number

40911

Product Number

1

Dosage Form

-

Strength

5%

Approval Date

2011-05-23

Regulatory Status

RX

1985
22 Jan
RX Application: 88389

Drug Name

LIGNOSPAN FORTE

Product Number

1

Dosage Form

-

Strength

EQ 0.02MG BASE/ML;2%

Approval Date

1985-01-22

88389 / 1

Active Ingredient

EPINEPHRINE BITARTRATE; LIDOCAINE HYDROCHLORIDE

Application Number

88389

Product Number

1

Dosage Form

-

Strength

EQ 0.02MG BASE/ML;2%

Approval Date

1985-01-22

Regulatory Status

RX

1985
22 Jan
RX Application: 88390

Drug Name

LIGNOSPAN STANDARD

Product Number

1

Dosage Form

-

Strength

EQ 0.01MG BASE/ML;2%

Approval Date

1985-01-22

88390 / 1

Active Ingredient

EPINEPHRINE BITARTRATE; LIDOCAINE HYDROCHLORIDE

Application Number

88390

Product Number

1

Dosage Form

-

Strength

EQ 0.01MG BASE/ML;2%

Approval Date

1985-01-22

Regulatory Status

RX

2008
09 May
RX Application: 22159

Drug Name

ORAVERSE

Product Number

1

Dosage Form

-

Strength

0.4MG/1.7ML

Approval Date

2008-05-09

22159 / 1

Active Ingredient

PHENTOLAMINE MESYLATE

Application Number

22159

Product Number

1

Dosage Form

-

Strength

0.4MG/1.7ML

Approval Date

2008-05-09

Regulatory Status

RX

2010
29 Sep
RX Application: 79235

Drug Name

PRILOCAINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

4%

Approval Date

2010-09-29

79235 / 1

Active Ingredient

PRILOCAINE HYDROCHLORIDE

Application Number

79235

Product Number

1

Dosage Form

-

Strength

4%

Approval Date

2010-09-29

Regulatory Status

RX

2011
30 Aug
RX Application: 78959

Drug Name

PRILOCAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE

Product Number

1

Dosage Form

-

Strength

0.005MG/ML;4%

Approval Date

2011-08-30

78959 / 1

Active Ingredient

EPINEPHRINE BITARTRATE; PRILOCAINE HYDROCHLORIDE

Application Number

78959

Product Number

1

Dosage Form

-

Strength

0.005MG/ML;4%

Approval Date

2011-08-30

Regulatory Status

RX

1984
10 Oct
RX Application: 88387

Drug Name

SCANDONEST PLAIN

Product Number

1

Dosage Form

-

Strength

3%

Approval Date

1984-10-10

88387 / 1

Active Ingredient

MEPIVACAINE HYDROCHLORIDE

Application Number

88387

Product Number

1

Dosage Form

-

Strength

3%

Approval Date

1984-10-10

Regulatory Status

RX

2000
03 Apr
RX Application: 20971

Drug Name

SEPTOCAINE

Product Number

1

Dosage Form

-

Strength

4%;EQ 0.017MG BASE/1.7ML (4%;EQ 0.01MG BASE/ML)

Approval Date

2000-04-03

20971 / 1

Active Ingredient

ARTICAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATE

Application Number

20971

Product Number

1

Dosage Form

-

Strength

4%;EQ 0.017MG BASE/1.7ML (4%;EQ 0.01MG BASE/ML)

Approval Date

2000-04-03

Regulatory Status

RX

2006
30 Mar
RX Application: 20971

Drug Name

SEPTOCAINE

Product Number

2

Dosage Form

-

Strength

4%; EQ 0.0085MG BASE/1.7ML (4%; EQ 0.005MG BASE/ML)

Approval Date

2006-03-30

20971 / 2

Active Ingredient

ARTICAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATE

Application Number

20971

Product Number

2

Dosage Form

-

Strength

4%; EQ 0.0085MG BASE/1.7ML (4%; EQ 0.005MG BASE/ML)

Approval Date

2006-03-30

Regulatory Status

RX

2006
27 Sep
RX Application: 77250

Drug Name

VIVACAINE

Product Number

1

Dosage Form

-

Strength

0.5%;0.0091MG/ML

Approval Date

2006-09-27

77250 / 1

Active Ingredient

BUPIVACAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATE

Application Number

77250

Product Number

1

Dosage Form

-

Strength

0.5%;0.0091MG/ML

Approval Date

2006-09-27

Regulatory Status

RX

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Drug Status Breakdown
13 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

DYCLOPRO

Application Number

200480

Product Number

1

Active Ingredient

DYCLONINE HYDROCHLORIDE

Dosage Form

-

Strength

0.5%

FDA Approved Drug Data

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