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SUPPRELIN

NDA

HISTRELIN ACETATE | N019836 | SHIRE DEVELOPMENT INC

3 strengths0 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

No ANDA patent litigation cases (NOS 835) matched from PACER

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

No clinical trials found on ClinicalTrials.gov for this drug

API Supply Chain1 active DMF

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

BACHEM AGHISTRELIN ACETATE

DMF 169972003

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

Products (3)

Sort:

#001 — EQ 0.2MG BASE/ML

0 patents0 exclusivities▴

INJECTABLE;INJECTION | Approved: Dec 24, 1991

No patent or exclusivity listings for this strength.

#002 — EQ 0.5MG BASE/ML

0 patents0 exclusivities▾

INJECTABLE;INJECTION | Approved: Dec 24, 1991

#003 — EQ 1MG BASE/ML

0 patents0 exclusivities▾

INJECTABLE;INJECTION | Approved: Dec 24, 1991