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DIABINESE

NDA

CHLORPROPAMIDE | N011641 | PFIZER LABORATORIES DIV PFIZER INC

2 strengths0 unique patents0 unique exclusivities

PTAB Proceedings

No IPR/PGR/CBM challenges found at the Patent Trial and Appeal Board

Patent Reexaminations

No ex parte or inter partes reexamination proceedings found at USPTO

Hatch-Waxman Litigation

No ANDA patent litigation cases (NOS 835) matched from PACER

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

No clinical trials found on ClinicalTrials.gov for this drug

API Supply Chain1 active DMF9 inactive

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

KOTHARI PHYTOCHEMICALS INTERNATIONALCHLORPROPAMIDE USP

DMF 251272011

UPJOHN COInactiveCHLORPROPAMIDE TABLETS-PHARMACOLOGY, CLIN RPTS,MFG'S PROCEEDS. & CNTRL

DMF 3041958

PLIVA PHARMACEUTICAL CHEMICAL FOOD & COSMETIC INDUSTRYInactiveCHLORPROPAMIDE

DMF 28851977

DIPHARMA FRANCIS SRLInactiveCHLORPROPAMIDE

DMF 35141979

HOECHST CELANESE CORPInactiveCHLORPROPAMIDE USP

DMF 54831984

ORTHO PHARMA PRIVATE LTDInactiveCHLORPROPAMIDE

DMF 54961984

SOCIEDAD MEXICANA DE QUIMICA INDUSTRIAL SAInactiveCHLORPROPAMIDE USP (BULK)

DMF 55891984

ALBERT DAVID LTDInactiveCHLORPROPAMIDE USP XX

DMF 58161985

KOTHARI PHYTOCHEMICALS INTERNATIONALInactiveCHLORPROPAMIDE AND TOLBUTAMIDE

DMF 61981986

PHARMACEUTICAL WORKS POLPHARMA SAInactiveCHLORPROPAMIDE

DMF 103841993

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

Approval Letters

5 letters from Drugs@FDA

Date	Submission	Document
Feb 4, 2011	SUPPL -66	View Letter (PDF)
Oct 29, 2008	SUPPL -64	View Letter (PDF)
Jan 9, 2004	SUPPL -61	View Letter (PDF)
May 16, 2002	SUPPL -58	View Letter (PDF)
May 16, 2002	SUPPL -60	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (2)

Sort:

#003 — 100MG

RLD

0 patents0 exclusivities▴

TABLET;ORAL | Approved: Approved Prior to Jan 1, 1982

No patent or exclusivity listings for this strength.

#006 — 250MG

RLD

0 patents0 exclusivities▾

TABLET;ORAL | Approved: Approved Prior to Jan 1, 1982