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HYDROCODONE BITARTRATE AND IBUPROFEN

ANDA

HYDROCODONE BITARTRATE; IBUPROFEN | A076642 | AMNEAL PHARMACEUTICALS NY LLC

4 strengths0 unique patents0 unique exclusivities

Approval Letters

4 letters from Drugs@FDA

Source: Drugs@FDA application documents.

Products (4)

Sort:

#001 — 7.5MG;200MG

0 patents0 exclusivities▴

TABLET;ORAL | Approved: Oct 12, 2004

No patent or exclusivity listings for this strength.

#002 — 5MG;200MG

0 patents0 exclusivities▾

TABLET;ORAL | Approved: Mar 18, 2004

#003 — 2.5MG;200MG

0 patents0 exclusivities▾

TABLET;ORAL | Approved: Oct 19, 2007

#004 — 10MG;200MG

0 patents0 exclusivities▾

TABLET;ORAL | Approved: Oct 19, 2007

Change History (1)

Recent changes detected for this application.

MODIFIEDtype7/1/2026

Amneal Pharmaceuticals' hydrocodone bitartrate and ibuprofen product (NDA 076642) changed from discontinued to active prescription drug status.

Old: DISCN

New: RX