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BUTORPHANOL TARTRATE

ANDA

BUTORPHANOL TARTRATE | A075824 | HIKMA PHARMACEUTICALS USA INC

1 strength0 unique patents0 unique exclusivities

API Supply Chain4 active DMFs3 inactive

4 active API suppliers hold Drug Master Files for this ingredient.

ABBVIE INCBUTORPHANOL TARTRATE

DMF 89041990

TAPI NL BVBUTORPHANOL TARTRATE

DMF 103851993

SRI KRISHNA PHARMACEUTICALS LTDBUTORPHANOL TARTRATE USP

DMF 256702012

HIKAL LTDBUTORPHANOL TARTRATE USP

DMF 318752017

NV ORGANONInactiveBUTORPHANOL TARTRATE

DMF 91271991

TASMANIAN ALKALOIDS PTY LTDInactiveBUTORPHANOL TARTRATE

DMF 121191996

ABBOTT LABORATORIES LTDInactiveBUTORPHANOL TARTRATE USP

DMF 129211998

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 10, 2003	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 1MG/SPRAY

0 patents0 exclusivities▴

SPRAY, METERED;NASAL | Approved: Mar 12, 2002

No patent or exclusivity listings for this strength.