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TRUPHYLLINE

ANDA

AMINOPHYLLINE | A085498 | COSETTE PHARMACEUTICALS NC LABORATORIES LLC

2 strengths0 unique patents0 unique exclusivities

API Supply Chain0 active DMFs1 inactive

0 active API suppliers hold Drug Master Files for this ingredient. Limited supplier base — potential supply chain risk.

KNOLL AG LUDWIGSHAFENInactiveAMINOPHYLLINE

DMF 49171983

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

Products (2)

Sort:

#001 — 250MG

0 patents0 exclusivities▴

SUPPOSITORY;RECTAL | Approved: Mar 23, 1983

No patent or exclusivity listings for this strength.

#002 — 500MG

0 patents0 exclusivities▾

SUPPOSITORY;RECTAL | Approved: Jan 3, 1983

Change History (4)

Recent changes detected for this application.

MODIFIEDApplicant7/1/2026

Cosette Pharmaceuticals updated its applicant name on the Truphylline (aminophylline) NDA from "Cosette" to "Cosette Pharms NC" in the FDA Orange Book.

Old: COSETTE

New: COSETTE PHARMS NC

MODIFIEDApplicant Full Name7/1/2026

Cosette Pharmaceuticals updated its registered entity name to Cosette Pharmaceuticals NC Laboratories LLC for aminophylline (Truphylline) NDA 085498.

Old: COSETTE PHARMACEUTICALS INC

New: COSETTE PHARMACEUTICALS NC LABORATORIES LLC