Application 074745

Type: ANDA
Sponsor: TEVA

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	MEGESTROL ACETATE	MEGESTROL ACETATE	TABLET;ORAL	40MG	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
A074745-001	MEGESTROL ACETATE	MEGESTROL ACETATE	40MG	TABLET / ORAL			1998-02-27

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 · 43 observed 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	A074745-001	MEGESTROL ACETATE	40MG	TABLET / ORAL	1998-02-27	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A074745-001	MEGESTROL ACETATE	40MG	TABLET / ORAL	1998-02-27	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A074745-001	MEGESTROL ACETATE	40MG	TABLET / ORAL	1998-02-27	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074745-001	MEGESTROL ACETATE	40MG	TABLET / ORAL	1998-02-27	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A074745-001	MEGESTROL ACETATE	40MG	TABLET / ORAL	1998-02-27	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074745-001	MEGESTROL ACETATE	40MG	TABLET / ORAL	1998-02-27	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074745-001	MEGESTROL ACETATE	40MG	TABLET / ORAL	1998-02-27	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074745-001	MEGESTROL ACETATE	40MG	TABLET / ORAL	1998-02-27	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074745-001	MEGESTROL ACETATE	40MG	TABLET / ORAL	1998-02-27	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074745-001	MEGESTROL ACETATE	40MG	TABLET / ORAL	1998-02-27	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074745-001	MEGESTROL ACETATE	40MG	TABLET / ORAL	1998-02-27	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A074745-001	MEGESTROL ACETATE	40MG	TABLET / ORAL	1998-02-27	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A074745-001	MEGESTROL ACETATE	40MG	TABLET / ORAL	1998-02-27	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A074745-001	MEGESTROL ACETATE	40MG	TABLET / ORAL	1998-02-27	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A074745-001	MEGESTROL ACETATE	40MG	TABLET / ORAL	1998-02-27	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A074745-001	MEGESTROL ACETATE	40MG	TABLET / ORAL	1998-02-27	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A074745-001	MEGESTROL ACETATE	40MG	TABLET / ORAL	1998-02-27	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A074745-001	MEGESTROL ACETATE	40MG	TABLET / ORAL	1998-02-27	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A074745-001	MEGESTROL ACETATE	40MG	TABLET / ORAL	1998-02-27	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A074745-001	MEGESTROL ACETATE	40MG	TABLET / ORAL	1998-02-27	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A074745-001	MEGESTROL ACETATE	40MG	TABLET / ORAL	1998-02-27	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A074745-001	MEGESTROL ACETATE	40MG	TABLET / ORAL	1998-02-27	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A074745-001	MEGESTROL ACETATE	40MG	TABLET / ORAL	1998-02-27	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A074745-001	MEGESTROL ACETATE	40MG	TABLET / ORAL	1998-02-27	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A074745-001	MEGESTROL ACETATE	40MG	TABLET / ORAL	1998-02-27	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A074745-001	MEGESTROL ACETATE	40MG	TABLET / ORAL	1998-02-27	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A074745-001	MEGESTROL ACETATE	40MG	TABLET / ORAL	1998-02-27	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A074745-001	MEGESTROL ACETATE	40MG	TABLET / ORAL	1998-02-27	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A074745-001	MEGESTROL ACETATE	40MG	TABLET / ORAL	1998-02-27	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A074745-001	MEGESTROL ACETATE	40MG	TABLET / ORAL	1998-02-27	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A074745-001	MEGESTROL ACETATE	40MG	TABLET / ORAL	1998-02-27	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A074745-001	MEGESTROL ACETATE	40MG	TABLET / ORAL	1998-02-27	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A074745-001	MEGESTROL ACETATE	40MG	TABLET / ORAL	1998-02-27	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A074745-001	MEGESTROL ACETATE	40MG	TABLET / ORAL	1998-02-27	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A074745-001	MEGESTROL ACETATE	40MG	TABLET / ORAL	1998-02-27	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A074745-001	MEGESTROL ACETATE	40MG	TABLET / ORAL	1998-02-27	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A074745-001	MEGESTROL ACETATE	40MG	TABLET / ORAL	1998-02-27	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A074745-001	MEGESTROL ACETATE	40MG	TABLET / ORAL	1998-02-27	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A074745-001	MEGESTROL ACETATE	40MG	TABLET / ORAL	1998-02-27	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A074745-001	MEGESTROL ACETATE	40MG	TABLET / ORAL	1998-02-27	`f41ea6bd6efb…`

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 2 of 2 · 21 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Megestrol Acetate	MEGESTROL ACETATE	Proficient Rx LP	6342df31-afce-4deb-b992-e08e2a4b2b77	2022-04-01	Warnings, Adverse reactions	Name fallback brand name: Megestrol Acetate generic name: MEGESTROL ACETATE

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
42866	ORIG	1998-02-17