Viewing data from:

PEMOLINE

ANDA

PEMOLINE | A075328 | VINTAGE PHARMACEUTICALS INC

3 strengths0 unique patents0 unique exclusivities

API Supply Chain1 active DMF5 inactive

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

KATWIJK CHEMIE BVPEMOLINE

DMF 117801995

HOECHST CELANESE CORPInactivePEMOLINE

DMF 122381996

ORGAMOL SAInactivePEMOLINE

DMF 127961997

PLIVA DDInactivePEMOLINE

DMF 139191998

MALLINCKRODT INCInactivePEMOLINE MALLINCKRODT CODE 1500

DMF 138651998

INNOVATIVE PHARMACY SOLUTIONS LLCInactivePEMOLINE 18.75 MG COMPOUNDED CAPSULES

DMF 312682016

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

Approval Letters

1 letter from Drugs@FDA

Date	Submission	Document
Apr 19, 2000	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (3)

Sort:

#001 — 18.75MG

0 patents0 exclusivities▴

TABLET;ORAL | Approved: Apr 19, 2000

No patent or exclusivity listings for this strength.

#002 — 37.5MG

0 patents0 exclusivities▾

TABLET;ORAL | Approved: Apr 19, 2000

#003 — 75MG

0 patents0 exclusivities▾

TABLET;ORAL | Approved: Apr 19, 2000