Viewing data from:

NITROGLYCERIN

ANDA

NITROGLYCERIN | A216103 | COSETTE PHARMACEUTICALS NC LABORATORIES LLC

1 strength0 unique patents0 unique exclusivities

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
Mar 7, 2024	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 0.4%

0 patents0 exclusivities▴

OINTMENT;INTRA-ANAL | Approved: Feb 16, 2024

No patent or exclusivity listings for this strength.

Change History (2)

Recent changes detected for this application.

MODIFIEDApplicant Full Name7/1/2026

COSETTE PHARMACEUTICALS INC updated its legal entity name to COSETTE PHARMACEUTICALS NC LABORATORIES LLC for the nitroglycerin NDA 216103.

Old: COSETTE PHARMACEUTICALS INC

New: COSETTE PHARMACEUTICALS NC LABORATORIES LLC

MODIFIEDApplicant7/1/2026

Cosette Pharmaceuticals updated its registered applicant name from "Cosette" to "Cosette Pharms NC" for the nitroglycerin product (NDA 216103).

Old: COSETTE

New: COSETTE PHARMS NC