Application 203139

Type: ANDA
Sponsor: TWI PHARMS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	MEGESTROL ACETATE	MEGESTROL ACETATE	SUSPENSION;ORAL	125MG/ML	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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
A203139-001	MEGESTROL ACETATE	MEGESTROL ACETATE	125MG/ML	SUSPENSION / ORAL		RS	2014-08-27

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 2 · 42 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
2026-08-18 06:07:40	2026-07	A203139-001	MEGESTROL ACETATE	125MG/ML	SUSPENSION / ORAL		RS	2014-08-27	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A203139-001	MEGESTROL ACETATE	125MG/ML	SUSPENSION / ORAL		RS	2014-08-27	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203139-001	MEGESTROL ACETATE	125MG/ML	SUSPENSION / ORAL		RS	2014-08-27	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A203139-001	MEGESTROL ACETATE	125MG/ML	SUSPENSION / ORAL		RS	2014-08-27	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203139-001	MEGESTROL ACETATE	125MG/ML	SUSPENSION / ORAL		RS	2014-08-27	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203139-001	MEGESTROL ACETATE	125MG/ML	SUSPENSION / ORAL	AB		2014-08-27	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203139-001	MEGESTROL ACETATE	125MG/ML	SUSPENSION / ORAL	AB		2014-08-27	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203139-001	MEGESTROL ACETATE	125MG/ML	SUSPENSION / ORAL	AB		2014-08-27	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203139-001	MEGESTROL ACETATE	125MG/ML	SUSPENSION / ORAL	AB		2014-08-27	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203139-001	MEGESTROL ACETATE	125MG/ML	SUSPENSION / ORAL	AB		2014-08-27	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A203139-001	MEGESTROL ACETATE	125MG/ML	SUSPENSION / ORAL	AB		2014-08-27	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203139-001	MEGESTROL ACETATE	125MG/ML	SUSPENSION / ORAL	AB		2014-08-27	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203139-001	MEGESTROL ACETATE	125MG/ML	SUSPENSION / ORAL	AB		2014-08-27	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203139-001	MEGESTROL ACETATE	125MG/ML	SUSPENSION / ORAL	AB		2014-08-27	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A203139-001	MEGESTROL ACETATE	125MG/ML	SUSPENSION / ORAL	AB		2014-08-27	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A203139-001	MEGESTROL ACETATE	125MG/ML	SUSPENSION / ORAL	AB		2014-08-27	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A203139-001	MEGESTROL ACETATE	125MG/ML	SUSPENSION / ORAL	AB		2014-08-27	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A203139-001	MEGESTROL ACETATE	125MG/ML	SUSPENSION / ORAL	AB		2014-08-27	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A203139-001	MEGESTROL ACETATE	125MG/ML	SUSPENSION / ORAL	AB		2014-08-27	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A203139-001	MEGESTROL ACETATE	125MG/ML	SUSPENSION / ORAL	AB		2014-08-27	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A203139-001	MEGESTROL ACETATE	125MG/ML	SUSPENSION / ORAL	AB		2014-08-27	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A203139-001	MEGESTROL ACETATE	125MG/ML	SUSPENSION / ORAL	AB		2014-08-27	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A203139-001	MEGESTROL ACETATE	125MG/ML	SUSPENSION / ORAL	AB		2014-08-27	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A203139-001	MEGESTROL ACETATE	125MG/ML	SUSPENSION / ORAL	AB		2014-08-27	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A203139-001	MEGESTROL ACETATE	125MG/ML	SUSPENSION / ORAL	AB		2014-08-27	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A203139-001	MEGESTROL ACETATE	125MG/ML	SUSPENSION / ORAL	AB		2014-08-27	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A203139-001	MEGESTROL ACETATE	125MG/ML	SUSPENSION / ORAL	AB		2014-08-27	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A203139-001	MEGESTROL ACETATE	125MG/ML	SUSPENSION / ORAL	AB		2014-08-27	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A203139-001	MEGESTROL ACETATE	125MG/ML	SUSPENSION / ORAL	AB		2014-08-27	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A203139-001	MEGESTROL ACETATE	125MG/ML	SUSPENSION / ORAL	AB		2014-08-27	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A203139-001	MEGESTROL ACETATE	125MG/ML	SUSPENSION / ORAL	AB		2014-08-27	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A203139-001	MEGESTROL ACETATE	125MG/ML	SUSPENSION / ORAL	AB		2014-08-27	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A203139-001	MEGESTROL ACETATE	125MG/ML	SUSPENSION / ORAL	AB		2014-08-27	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A203139-001	MEGESTROL ACETATE	125MG/ML	SUSPENSION / ORAL	AB		2014-08-27	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A203139-001	MEGESTROL ACETATE	125MG/ML	SUSPENSION / ORAL	AB		2014-08-27	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A203139-001	MEGESTROL ACETATE	125MG/ML	SUSPENSION / ORAL	AB		2014-08-27	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A203139-001	MEGESTROL ACETATE	125MG/ML	SUSPENSION / ORAL	AB		2014-08-27	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A203139-001	MEGESTROL ACETATE	125MG/ML	SUSPENSION / ORAL	AB		2014-08-27	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A203139-001	MEGESTROL ACETATE	125MG/ML	SUSPENSION / ORAL	AB		2014-08-27	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A203139-001	MEGESTROL ACETATE	125MG/ML	SUSPENSION / ORAL	AB		2014-08-27	`e64feba35796…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203139-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203139-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203139-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203139-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203139-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A203139-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203139-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203139-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203139-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A203139-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A203139-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A203139-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A203139-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A203139-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A203139-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A203139-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A203139-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A203139-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A203139-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A203139-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A203139-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A203139-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A203139-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A203139-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A203139-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A203139-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A203139-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A203139-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A203139-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A203139-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A203139-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A203139-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A203139-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A203139-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A203139-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A203139-001	AB	1	`cb3db0bc1861…`

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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Megestrol Acetate	MEGESTROL ACETATE	Upsher-Smith Laboratories, LLC	2dc921d5-e423-4379-a345-151e87d13651	2026-04-14	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203139 application number: ANDA203139 ndc (product): 24979-041
Megestrol Acetate	MEGESTROL ACETATE	Proficient Rx LP	6342df31-afce-4deb-b992-e08e2a4b2b77	2022-04-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203139 application number: ANDA203139 ndc (product): 71205-943

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 4 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
24979-041	Megestrol Acetate	Megestrol Acetate	TWi Pharmaceuticals, Inc.	ANDA	Current
24979-041	Megestrol Acetate	Megestrol Acetate	TWi Pharmaceuticals, Inc.	ANDA	Current
71205-943	Megestrol Acetate	Megestrol Acetate	Proficient Rx LP	ANDA	Current
71205-943	Megestrol Acetate	Megestrol Acetate	Proficient Rx LP	ANDA	Current