Application 072423

Type: ANDA
Sponsor: PAR PHARM

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	MEGESTROL ACETATE	MEGESTROL ACETATE	TABLET;ORAL	40MG	No	Yes

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
A072423-001	MEGESTROL ACETATE	MEGESTROL ACETATE	40MG	TABLET / ORAL	AB	RS	1988-08-08

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-product	TE code
A072423-001	AB

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	A072423-001	MEGESTROL ACETATE	40MG	TABLET / ORAL	AB	RS	1988-08-08	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A072423-001	MEGESTROL ACETATE	40MG	TABLET / ORAL	AB	RS	1988-08-08	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A072423-001	MEGESTROL ACETATE	40MG	TABLET / ORAL	AB	RS	1988-08-08	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A072423-001	MEGESTROL ACETATE	40MG	TABLET / ORAL	AB	RS	1988-08-08	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A072423-001	MEGESTROL ACETATE	40MG	TABLET / ORAL	AB	RS	1988-08-08	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A072423-001	MEGESTROL ACETATE	40MG	TABLET / ORAL	AB	RS	1988-08-08	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A072423-001	MEGESTROL ACETATE	40MG	TABLET / ORAL	AB	RS	1988-08-08	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A072423-001	MEGESTROL ACETATE	40MG	TABLET / ORAL	AB	RS	1988-08-08	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A072423-001	MEGESTROL ACETATE	40MG	TABLET / ORAL	AB	RS	1988-08-08	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A072423-001	MEGESTROL ACETATE	40MG	TABLET / ORAL	AB	RS	1988-08-08	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A072423-001	MEGESTROL ACETATE	40MG	TABLET / ORAL	AB	RS	1988-08-08	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A072423-001	MEGESTROL ACETATE	40MG	TABLET / ORAL	AB	RS	1988-08-08	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A072423-001	MEGESTROL ACETATE	40MG	TABLET / ORAL	AB	RS	1988-08-08	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A072423-001	MEGESTROL ACETATE	40MG	TABLET / ORAL	AB	RS	1988-08-08	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A072423-001	MEGESTROL ACETATE	40MG	TABLET / ORAL	AB	RS	1988-08-08	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A072423-001	MEGESTROL ACETATE	40MG	TABLET / ORAL	AB	RS	1988-08-08	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A072423-001	MEGESTROL ACETATE	40MG	TABLET / ORAL	AB	RS	1988-08-08	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A072423-001	MEGESTROL ACETATE	40MG	TABLET / ORAL	AB	RS	1988-08-08	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A072423-001	MEGESTROL ACETATE	40MG	TABLET / ORAL	AB	RS	1988-08-08	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A072423-001	MEGESTROL ACETATE	40MG	TABLET / ORAL	AB	RS	1988-08-08	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A072423-001	MEGESTROL ACETATE	40MG	TABLET / ORAL	AB	RS	1988-08-08	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A072423-001	MEGESTROL ACETATE	40MG	TABLET / ORAL	AB	RS	1988-08-08	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A072423-001	MEGESTROL ACETATE	40MG	TABLET / ORAL	AB	RS	1988-08-08	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A072423-001	MEGESTROL ACETATE	40MG	TABLET / ORAL	AB	RS	1988-08-08	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A072423-001	MEGESTROL ACETATE	40MG	TABLET / ORAL	AB	RS	1988-08-08	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A072423-001	MEGESTROL ACETATE	40MG	TABLET / ORAL	AB	RS	1988-08-08	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A072423-001	MEGESTROL ACETATE	40MG	TABLET / ORAL	AB	RS	1988-08-08	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A072423-001	MEGESTROL ACETATE	40MG	TABLET / ORAL	AB	RS	1988-08-08	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A072423-001	MEGESTROL ACETATE	40MG	TABLET / ORAL	AB	RS	1988-08-08	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A072423-001	MEGESTROL ACETATE	40MG	TABLET / ORAL	AB	RS	1988-08-08	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A072423-001	MEGESTROL ACETATE	40MG	TABLET / ORAL	AB	RS	1988-08-08	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A072423-001	MEGESTROL ACETATE	40MG	TABLET / ORAL	AB	RS	1988-08-08	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A072423-001	MEGESTROL ACETATE	40MG	TABLET / ORAL	AB	RS	1988-08-08	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A072423-001	MEGESTROL ACETATE	40MG	TABLET / ORAL	AB	RS	1988-08-08	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A072423-001	MEGESTROL ACETATE	40MG	TABLET / ORAL	AB	RS	1988-08-08	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A072423-001	MEGESTROL ACETATE	40MG	TABLET / ORAL	AB	RS	1988-08-08	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A072423-001	MEGESTROL ACETATE	40MG	TABLET / ORAL	AB	RS	1988-08-08	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A072423-001	MEGESTROL ACETATE	40MG	TABLET / ORAL	AB	RS	1988-08-08	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A072423-001	MEGESTROL ACETATE	40MG	TABLET / ORAL	AB	RS	1988-08-08	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A072423-001	MEGESTROL ACETATE	40MG	TABLET / ORAL	AB	RS	1988-08-08	`e64feba35796…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 42 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A072423-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A072423-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A072423-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A072423-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A072423-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A072423-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A072423-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A072423-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A072423-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A072423-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A072423-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A072423-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A072423-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A072423-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A072423-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A072423-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A072423-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A072423-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A072423-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A072423-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A072423-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A072423-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A072423-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A072423-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A072423-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A072423-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A072423-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A072423-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A072423-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A072423-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A072423-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A072423-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A072423-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A072423-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A072423-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A072423-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A072423-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A072423-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A072423-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A072423-001	AB	1	`e64feba35796…`

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 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Megestrol Acetate	MEGESTROL ACETATE	Major Pharmaceuticals	2c755c6b-32e9-4029-8b70-855007f7375b	2025-09-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 072423 application number: ANDA072423 ndc (product): 0904-7236
Megestrol Acetate	MEGESTROL ACETATE	Bryant Ranch Prepack	dd6617df-0876-4fc5-8435-b53d29ccc1ae	2025-03-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 072423 application number: ANDA072423 ndc (product): 71335-2181
Megestrol Acetate	MEGESTROL ACETATE	Strides Pharma Science Limited	8ec70070-da70-4a38-9d58-cf2278517661	2025-02-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 072423 application number: ANDA072423 ndc (product): 64380-159

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 23 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0615-3570	Megestrol Acetate	Megestrol Acetate	NCS HealthCare of KY, Inc dba Vangard Labs	ANDA	Current
0904-3571	Megestrol Acetate	Megestrol Acetate	Major Pharmaceuticals	ANDA	Current
0904-3571	Megestrol Acetate	Megestrol Acetate	Major Pharmaceuticals	ANDA	Current
0904-3571	Megestrol Acetate	Megestrol Acetate	Major Pharmaceuticals	ANDA	Current
0904-7236	Megestrol Acetate	Megestrol Acetate	Major Pharmaceuticals	ANDA	Current
49884-290	Megestrol Acetate	Megestrol Acetate	Par Pharmaceutical, Inc.	ANDA	Current
49884-290	Megestrol Acetate	Megestrol Acetate	Par Pharmaceutical, Inc.	ANDA	Current
49884-290	Megestrol Acetate	Megestrol Acetate	Par Pharmaceutical, Inc.	ANDA	Current
60429-433	Megestrol Acetate	Megestrol Acetate	Golden State Medical Supply, Inc.	ANDA	Current
63629-2219	Megestrol Acetate	Megestrol Acetate	Bryant Ranch Prepack	ANDA	Current
63629-2219	Megestrol Acetate	Megestrol Acetate	Bryant Ranch Prepack	ANDA	Current
63629-2220	Megestrol Acetate	Megestrol Acetate	Bryant Ranch Prepack	ANDA	Current
63629-2220	Megestrol Acetate	Megestrol Acetate	Bryant Ranch Prepack	ANDA	Current
63629-7631	Megestrol Acetate	Megestrol Acetate	Bryant Ranch Prepack	ANDA	Current
63629-7631	Megestrol Acetate	Megestrol Acetate	Bryant Ranch Prepack	ANDA	Current
63629-7631	Megestrol Acetate	Megestrol Acetate	Bryant Ranch Prepack	ANDA	Current
63629-7631	Megestrol Acetate	Megestrol Acetate	Bryant Ranch Prepack	ANDA	Current
63739-165	Megestrol Acetate	Megestrol Acetate	McKesson Corporation	ANDA	Current
63739-165	Megestrol Acetate	Megestrol Acetate	McKesson Corporation dba SKY Packaging	ANDA	Current
63739-165	Megestrol Acetate	Megestrol Acetate	McKesson Corporation dba SKY Packaging	ANDA	Current
64380-159	Megestrol Acetate	Megestrol Acetate	Strides Pharma Science Limited	ANDA	Current
64380-159	Megestrol Acetate	Megestrol Acetate	Strides Pharma Science Limited	ANDA	Current
71335-2181	Megestrol Acetate	Megestrol Acetate	Bryant Ranch Prepack	ANDA	Current