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TINIDAZOLE

ANDA

TINIDAZOLE | A202489 | UNIQUE PHARMACEUTICAL LABORATORIES A DIV OF JB CHEMICALS AND PHARMACEUTICALS LTD

2 strengths0 unique patents0 unique exclusivities

Reference Listed Drug: TINDAMAX(TE code: AB)

API Supply Chain1 active DMF5 inactive

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

ZHEJIANG SUPOR PHARMACEUTICALS CO LTDTINIDAZOLE (NON-STERILE DRUG SUBSTANCE)

DMF 188242005

PFIZER INCInactiveTINIDAZOLE BULK

DMF 17041971

PFIZER LABORATORIES DIV PFIZER INCInactiveTINIDAZOLE

DMF 62261985

FARCHEMIA SRLInactiveTINIDAZOLE USP XXI

DMF 62751986

PFIZER SAInactiveTINIDAZOLE

DMF 65441986

ZAKLADY FARMACEUTYCZNE POLPHARMA SAInactiveTINIDAZOLE

DMF 103501993

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

Approval Letters

1 letter from Drugs@FDA

Date	Submission	Document
Oct 11, 2013	SUPPL -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (2)

Sort:

#001 — 250MG

0 patents0 exclusivities▴

TABLET;ORAL | Approved: Oct 9, 2013

No patent or exclusivity listings for this strength.

#002 — 500MG

0 patents0 exclusivities▾

TABLET;ORAL | Approved: Oct 9, 2013