Application 077827

Type: ANDA
Sponsor: PAR PHARM

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	OXANDROLONE	OXANDROLONE	TABLET;ORAL	2.5MG	No	No
002	OXANDROLONE	OXANDROLONE	TABLET;ORAL	10MG	No	Yes

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

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A077827-001	OXANDROLONE	OXANDROLONE	2.5MG	TABLET / ORAL			2007-06-22
A077827-002	OXANDROLONE	OXANDROLONE	10MG	TABLET / ORAL			2007-06-22

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 1 of 3 · 86 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A077827-001	OXANDROLONE	2.5MG	TABLET / ORAL			2007-06-22	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A077827-002	OXANDROLONE	10MG	TABLET / ORAL			2007-06-22	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A077827-001	OXANDROLONE	2.5MG	TABLET / ORAL			2007-06-22	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077827-002	OXANDROLONE	10MG	TABLET / ORAL			2007-06-22	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A077827-001	OXANDROLONE	2.5MG	TABLET / ORAL			2007-06-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077827-002	OXANDROLONE	10MG	TABLET / ORAL			2007-06-22	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077827-001	OXANDROLONE	2.5MG	TABLET / ORAL			2007-06-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077827-002	OXANDROLONE	10MG	TABLET / ORAL			2007-06-22	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077827-001	OXANDROLONE	2.5MG	TABLET / ORAL			2007-06-22	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077827-002	OXANDROLONE	10MG	TABLET / ORAL			2007-06-22	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077827-001	OXANDROLONE	2.5MG	TABLET / ORAL			2007-06-22	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077827-002	OXANDROLONE	10MG	TABLET / ORAL			2007-06-22	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077827-001	OXANDROLONE	2.5MG	TABLET / ORAL			2007-06-22	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077827-002	OXANDROLONE	10MG	TABLET / ORAL			2007-06-22	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077827-001	OXANDROLONE	2.5MG	TABLET / ORAL			2007-06-22	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077827-002	OXANDROLONE	10MG	TABLET / ORAL			2007-06-22	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077827-001	OXANDROLONE	2.5MG	TABLET / ORAL			2007-06-22	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077827-002	OXANDROLONE	10MG	TABLET / ORAL			2007-06-22	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077827-001	OXANDROLONE	2.5MG	TABLET / ORAL			2007-06-22	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077827-002	OXANDROLONE	10MG	TABLET / ORAL			2007-06-22	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077827-001	OXANDROLONE	2.5MG	TABLET / ORAL			2007-06-22	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077827-002	OXANDROLONE	10MG	TABLET / ORAL			2007-06-22	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A077827-001	OXANDROLONE	2.5MG	TABLET / ORAL			2007-06-22	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077827-002	OXANDROLONE	10MG	TABLET / ORAL			2007-06-22	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077827-001	OXANDROLONE	2.5MG	TABLET / ORAL			2007-06-22	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077827-002	OXANDROLONE	10MG	TABLET / ORAL			2007-06-22	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077827-001	OXANDROLONE	2.5MG	TABLET / ORAL			2007-06-22	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077827-002	OXANDROLONE	10MG	TABLET / ORAL			2007-06-22	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077827-001	OXANDROLONE	2.5MG	TABLET / ORAL			2007-06-22	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077827-002	OXANDROLONE	10MG	TABLET / ORAL			2007-06-22	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A077827-001	OXANDROLONE	2.5MG	TABLET / ORAL			2007-06-22	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A077827-002	OXANDROLONE	10MG	TABLET / ORAL			2007-06-22	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A077827-001	OXANDROLONE	2.5MG	TABLET / ORAL	AB		2007-06-22	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A077827-002	OXANDROLONE	10MG	TABLET / ORAL	AB	RS	2007-06-22	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A077827-001	OXANDROLONE	2.5MG	TABLET / ORAL	AB		2007-06-22	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A077827-002	OXANDROLONE	10MG	TABLET / ORAL	AB	RS	2007-06-22	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A077827-001	OXANDROLONE	2.5MG	TABLET / ORAL	AB		2007-06-22	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A077827-002	OXANDROLONE	10MG	TABLET / ORAL	AB	RS	2007-06-22	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A077827-001	OXANDROLONE	2.5MG	TABLET / ORAL	AB		2007-06-22	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A077827-002	OXANDROLONE	10MG	TABLET / ORAL	AB	RS	2007-06-22	`74a2ff9319b5…`

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	A077827-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A077827-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A077827-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A077827-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A077827-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A077827-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A077827-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A077827-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A077827-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A077827-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A077827-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A077827-002	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A077827-001	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A077827-002	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A077827-001	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A077827-002	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A077827-001	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A077827-002	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A077827-001	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A077827-002	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A077827-001	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A077827-002	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A077827-001	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A077827-002	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A077827-001	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A077827-002	AB	1	`ea99ee380514…`
2023-01-26 05:58 UTC	2023-01	A077827-001	AB	1	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	A077827-002	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A077827-001	AB	1	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A077827-002	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A077827-001	AB	1	`f41ea6bd6efb…`
2022-10-28 04:53 UTC	2022-10	A077827-002	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A077827-001	AB	1	`e64feba35796…`
2022-09-29 23:25 UTC	2022-09	A077827-002	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A077827-001	AB	1	`cb3db0bc1861…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A077827-002	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 · 11 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
49884-301	Oxandrolone	oxandrolone	Par Pharmaceutical, Inc.	ANDA	Current
49884-301	Oxandrolone	oxandrolone	Par Pharmaceutical, Inc.	ANDA	Current
49884-301	Oxandrolone	oxandrolone	Par Pharmaceutical, Inc.	ANDA	Current
49884-302	Oxandrolone	oxandrolone	Par Pharmaceutical, Inc.	ANDA	Current
49884-302	Oxandrolone	oxandrolone	Par Pharmaceutical, Inc.	ANDA	Current
49884-302	Oxandrolone	oxandrolone	Par Pharmaceutical, Inc.	ANDA	Current
63629-7603	Oxandrolone	oxandrolone	Bryant Ranch Prepack	ANDA	Current
63629-7603	Oxandrolone	oxandrolone	Bryant Ranch Prepack	ANDA	Current
63629-7603	Oxandrolone	oxandrolone	Bryant Ranch Prepack	ANDA	Current
68084-424	Oxandrolone	oxandrolone	American Health Packaging	ANDA	Current
68084-425	Oxandrolone	oxandrolone	American Health Packaging	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
31291	SUPPL	2008-01-09