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NITROGLYCERIN

ANDA

NITROGLYCERIN | A208191 | DR REDDYS LABORATORIES INC

3 strengths0 unique patents0 unique exclusivities

Reference Listed Drug: NITROSTAT(TE code: AB)

API Supply Chain3 active DMFs3 inactive

3 active API suppliers hold Drug Master Files for this ingredient.

DYNAMIT NOBEL GMBH EXPLOSIVSTOFF UND SYSTEMTECHNIKNITROGLYCERIN

DMF 85241990

COPPERHEAD INVESTMENTS INCNITROGLYCERIN

DMF 115951995

BHARAT PHARMA (A UNIT OF BHARAT EXPLOSIVES LTD)NITROGLYCERIN AS IN DILUTED NITROGLYCERIN, USP

DMF 224352009

VICTOR M HERMELIN CO DIV K-V PHARMACAL COInactiveNITROGLYCERIN

DMF 9781966

ELI LILLY AND COInactiveNITROGLYCERIN AMPOULES

DMF 19231972

DYNAMIT NOBEL AGInactiveNITROGLYCERIN 5% IN MIGLYOL 829

DMF 68471987

Source: FDA Drug Master Files (fda.gov). Type II API DMFs matched by ingredient.

Approval Letters

1 letter from Drugs@FDA

Date	Submission	Document
Aug 31, 2016	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (3)

Sort:

#001 — 0.3MG

0 patents0 exclusivities▴

TABLET;SUBLINGUAL | Approved: Aug 26, 2016

No patent or exclusivity listings for this strength.

#002 — 0.4MG

0 patents0 exclusivities▾

TABLET;SUBLINGUAL | Approved: Aug 26, 2016

#003 — 0.6MG

0 patents0 exclusivities▾

TABLET;SUBLINGUAL | Approved: Aug 26, 2016