Viewing data from:

ESTROPIPATE

ANDA

ESTROPIPATE | A040296 | DURAMED PHARMACEUTICALS INC SUB BARR LABORATORIES INC

3 strengths0 unique patents0 unique exclusivities

API Supply Chain0 active DMFs2 inactive

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

PRODUCTOS QUIMICOS NATURALES SA DE CVInactiveESTROPIPATE

DMF 34091978

NEPERA INCInactiveESTROPIPATE

DMF 83471989

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

Approval Letters

1 letter from Drugs@FDA

Date	Submission	Document
Nov 1, 1999	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (3)

Sort:

#001 — 0.75MG

0 patents0 exclusivities▴

TABLET;ORAL | Approved: Nov 1, 1999

No patent or exclusivity listings for this strength.

#002 — 1.5MG

0 patents0 exclusivities▾

TABLET;ORAL | Approved: Nov 1, 1999

#003 — 3MG

0 patents0 exclusivities▾

TABLET;ORAL | Approved: Nov 1, 1999