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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, Mylan Technologies, Hercon Pharm, Dr Reddys Labs Inc, Perrigo Israel, and Baxter Hlthcare, and is included in twenty-two NDAs. It is available from eleven 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-six 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

Dr Reddys Labs Inc
Therapeutic Class:Cardiovascular Agents

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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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.