Application 208592

Type: ANDA
Sponsor: MYLAN LABS LTD

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	METHYLNALTREXONE BROMIDE	METHYLNALTREXONE BROMIDE	INJECTABLE;SUBCUTANEOUS	12MG/0.6ML	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A208592-001	METHYLNALTREXONE BROMIDE	METHYLNALTREXONE BROMIDE	12MG/0.6ML (12MG/0.6ML)	SOLUTION / SUBCUTANEOUS			2025-05-28

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A208592-001	METHYLNALTREXONE BROMIDE	12MG/0.6ML (12MG/0.6ML)	SOLUTION / SUBCUTANEOUS	2025-05-28	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A208592-001	METHYLNALTREXONE BROMIDE	12MG/0.6ML (12MG/0.6ML)	SOLUTION / SUBCUTANEOUS	2025-05-28	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A208592-001	METHYLNALTREXONE BROMIDE	12MG/0.6ML (12MG/0.6ML)	SOLUTION / SUBCUTANEOUS	2025-05-28	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208592-001	METHYLNALTREXONE BROMIDE	12MG/0.6ML (12MG/0.6ML)	SOLUTION / SUBCUTANEOUS	2025-05-28	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A208592-001	METHYLNALTREXONE BROMIDE	12MG/0.6ML (12MG/0.6ML)	SOLUTION / SUBCUTANEOUS	2025-05-28	`6a471c1ec25d…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A208592-001	METHYLNALTREXONE BROMIDE	12MG/0.6ML (12MG/0.6ML)	SOLUTION / SUBCUTANEOUS	2025-05-28	`a50c72e98297…`

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Relistor	METHYLNALTREXONE BROMIDE	Salix Pharmaceuticals, Inc.	c488fb7c-0a5b-487c-b452-996809d1cb99	2024-05-01	Warnings, Adverse reactions	Name fallback generic name: METHYLNALTREXONE BROMIDE

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Documents#

Document, Submission type, Date table
Document	Submission type	Date
48653	ORIG	2017-06-06