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STADOL

NDA

BUTORPHANOL TARTRATE | N019890 | BRISTOL MYERS SQUIBB CO PHARMACEUTICAL RESEARCH INSTITUTE

1 strength0 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

Para IV certification filed but no ANDA patent litigation cases (NOS 835) matched from PACER. Litigation may be pending or filed under a different caption.

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

No clinical trials found on ClinicalTrials.gov for this drug

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
Jan 14, 2002	SUPPL -17	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 1MG/SPRAY **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

0 patents0 exclusivities▴

SPRAY, METERED;NASAL | Approved: Dec 12, 1991

No patent or exclusivity listings for this strength.