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Approved Drug Products containing Nitroglycerin listed in the FDA Orange Book. Original Data : FDA Website

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01 2SANOFI AVENTIS US

02 1ABBVIE

03 3DR REDDYS

04 2ABRAXIS PHARM

05 3ACTAVIS LABS FL INC

06 1AM REGENT

07 3AUROBINDO PHARMA

08 1BAUSCH

09 3BAXTER HLTHCARE

10 1COSETTE

11 1EVUS

12 1FOUGERA PHARMS INC

13 3GLENMARK SPECLT

14 7HOSPIRA

15 1INTL MEDICATION

16 2LANNETT CO INC

17 1LUITPOLD

18 3MANKIND PHARMA

19 11MYLAN TECHNOLOGIES

20 3NATCO

21 5NOVARTIS

22 3NOVEN

23 1PADAGIS ISRAEL

24 5PARKE DAVIS

25 5POHL BOSKAMP

26 2QUAD PHARMS

27 1RORER

28 3RUBICON

29 3SIGMAPHARM LABS LLC

30 2SMITH AND NEPHEW

31 6USPHARMA

32 2VALEANT PHARMS

33 1VALEANT PHARMS NORTH

34 3VIATRIS

35 7ZYDUS PHARMS

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PharmaCompass

01

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AAPS 2024
Not Confirmed
  • fda
  • EDQM
  • WHO-GMP

Virtual BoothSanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.

RLD : No

TE Code :

NITROGLYCERIN

Brand Name : NITRO-BID

Dosage Form : INJECTABLE;INJECTION

Dosage Strength : 5MG/ML

Approval Date : 1982-01-05

Application Number : 18621

RX/OTC/DISCN : DISCN

RLD : No

TE Code :

Sanofi Company Banner

02

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AAPS 2024
Not Confirmed

NITROGLYCERIN

Brand Name : RECTIV

Dosage Form : OINTMENT;INTRA-ANAL

Dosage Strength : 0.4%

Approval Date : 2011-06-21

Application Number : 21359

RX/OTC/DISCN : RX

RLD : Yes

TE Code : AB

Abbvie Company Banner

03

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothDRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.

RLD : No

TE Code : AB

NITROGLYCERIN

Brand Name : NITROGLYCERIN

Dosage Form : TABLET;SUBLINGUAL

Dosage Strength : 0.3MG

Approval Date : 2016-08-26

Application Number : 208191

RX/OTC/DISCN : RX

RLD : No

TE Code : AB

Dr Reddy Company Banner

04

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AAPS 2024
Not Confirmed
  • fda
  • EDQM
  • WHO-GMP

Virtual BoothSanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.

RLD : No

TE Code :

NITROGLYCERIN

Brand Name : NITRO-BID

Dosage Form : INJECTABLE;INJECTION

Dosage Strength : 10MG/ML

Approval Date : 1990-02-28

Application Number : 71159

RX/OTC/DISCN : DISCN

RLD : No

TE Code :

Sanofi Company Banner

05

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothDRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.

RLD : No

TE Code : AB

NITROGLYCERIN

Brand Name : NITROGLYCERIN

Dosage Form : TABLET;SUBLINGUAL

Dosage Strength : 0.4MG

Approval Date : 2016-08-26

Application Number : 208191

RX/OTC/DISCN : RX

RLD : No

TE Code : AB

Dr Reddy Company Banner

06

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothDRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.

RLD : No

TE Code : AB

NITROGLYCERIN

Brand Name : NITROGLYCERIN

Dosage Form : TABLET;SUBLINGUAL

Dosage Strength : 0.6MG

Approval Date : 2016-08-26

Application Number : 208191

RX/OTC/DISCN : RX

RLD : No

TE Code : AB

Dr Reddy Company Banner

07

AAPS 2024
Not Confirmed
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AAPS 2024
Not Confirmed

NITROGLYCERIN

Brand Name : NITROGLYCERIN

Dosage Form : INJECTABLE;INJECTION

Dosage Strength : 5MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date : 1982-01-01

Application Number : 18531

RX/OTC/DISCN : DISCN

RLD : Yes

TE Code :

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08

AAPS 2024
Not Confirmed
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AAPS 2024
Not Confirmed

NITROGLYCERIN

Brand Name : TRIDIL

Dosage Form : INJECTABLE;INJECTION

Dosage Strength : 5MG/ML

Approval Date : 1982-01-01

Application Number : 18537

RX/OTC/DISCN : DISCN

RLD : No

TE Code :

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09

AAPS 2024
Not Confirmed
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AAPS 2024
Not Confirmed

NITROGLYCERIN

Brand Name : TRIDIL

Dosage Form : INJECTABLE;INJECTION

Dosage Strength : 0.5MG/ML

Approval Date : 1983-06-16

Application Number : 18537

RX/OTC/DISCN : DISCN

RLD : No

TE Code :

blank

10

AAPS 2024
Not Confirmed
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AAPS 2024
Not Confirmed

NITROGLYCERIN

Brand Name : NITROSTAT

Dosage Form : INJECTABLE;INJECTION

Dosage Strength : 0.8MG/ML

Approval Date : 1982-01-01

Application Number : 18588

RX/OTC/DISCN : DISCN

RLD : No

TE Code :

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