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Details for New Drug Application (NDA): 208191

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NDA 208191 describes NITROGLYCERIN, which is a drug marketed by Abraxis Pharm, Kremers Urban Pharms, Intl Medication, Hospira, Smith And Nephew, Luitpold, Fougera Pharms Inc, Mylan Technologies, Hercon Pharm, Dr Reddys Labs Inc, Perrigo Israel, and Baxter Hlthcare, and is included in twenty-two NDAs. It is available from thirteen suppliers. Additional details are available on the NITROGLYCERIN profile page.

The generic ingredient in NITROGLYCERIN is nitroglycerin. There are thirty-six drug master file entries for this compound. Thirty-eight suppliers are listed for this compound. There are three tentative approvals for this compound. Additional details are available on the nitroglycerin profile page.

Summary for NDA: 208191

Therapeutic Class:Cardiovascular Agents
Formulation / Manufacturing:see details

Pharmacology for NDA: 208191

Physiological EffectVasodilation

Suppliers and Packaging for NDA: 208191

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
TABLET;SUBLINGUAL 208191 ANDA Dr. Reddys Laboratories Inc 43598-435 43598-435-01 100 TABLET in 1 BOTTLE (43598-435-01)
TABLET;SUBLINGUAL 208191 ANDA Dr. Reddys Laboratories Inc 43598-436 43598-436-01 100 TABLET in 1 BOTTLE (43598-436-01)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;SUBLINGUALStrength0.3MG
Approval Date:Aug 26, 2016TE:ABRLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;SUBLINGUALStrength0.4MG
Approval Date:Aug 26, 2016TE:ABRLD:No

Summary for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;SUBLINGUALStrength0.6MG
Approval Date:Aug 26, 2016TE:ABRLD:No

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