Application 076761

Type: ANDA
Sponsor: UPSHER SMITH LABS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	OXANDROLONE	OXANDROLONE	TABLET;ORAL	2.5MG	No	No

Source provenance: Browse the complete Orange Book source catalog.

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.

Product history page 2 of 2 · 43 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2022-09-29 23:25 UTC	2022-09	A076761-001	OXANDROLONE	2.5MG	TABLET / ORAL	AB	2006-12-01	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A076761-001	OXANDROLONE	2.5MG	TABLET / ORAL	AB	2006-12-01	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A076761-001	OXANDROLONE	2.5MG	TABLET / ORAL		2006-12-01	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A076761-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A076761-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A076761-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A076761-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A076761-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A076761-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A076761-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A076761-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A076761-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A076761-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A076761-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A076761-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A076761-001	AB	1	`ea99ee380514…`
2023-01-26 05:58 UTC	2023-01	A076761-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A076761-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A076761-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A076761-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A076761-001	AB	1	`cb3db0bc1861…`

Reported adverse events (FAERS/openFDA)#

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

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 2 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0245-0271	Oxandrolone	Oxandrolone	Upsher-Smith Laboratories, LLC	ANDA	Current
0245-0271	Oxandrolone	Oxandrolone	Upsher-Smith Laboratories, LLC	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
22585	ORIG	2007-07-06
31161	ORIG	2006-12-06
18451	ORIG	2006-12-04