Application 075671

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	SUSPENSION;ORAL	40MG/ML	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
A075671-001	MEGESTROL ACETATE	MEGESTROL ACETATE	40MG/ML	SUSPENSION / ORAL	AB	RS	2001-07-25

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A075671-001	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	A075671-001	MEGESTROL ACETATE	40MG/ML	SUSPENSION / ORAL	AB	RS	2001-07-25	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A075671-001	MEGESTROL ACETATE	40MG/ML	SUSPENSION / ORAL	AB	RS	2001-07-25	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075671-001	MEGESTROL ACETATE	40MG/ML	SUSPENSION / ORAL	AB	RS	2001-07-25	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075671-001	MEGESTROL ACETATE	40MG/ML	SUSPENSION / ORAL	AB	RS	2001-07-25	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075671-001	MEGESTROL ACETATE	40MG/ML	SUSPENSION / ORAL	AB	RS	2001-07-25	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075671-001	MEGESTROL ACETATE	40MG/ML	SUSPENSION / ORAL	AB	RS	2001-07-25	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075671-001	MEGESTROL ACETATE	40MG/ML	SUSPENSION / ORAL	AB	RS	2001-07-25	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075671-001	MEGESTROL ACETATE	40MG/ML	SUSPENSION / ORAL	AB	RS	2001-07-25	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075671-001	MEGESTROL ACETATE	40MG/ML	SUSPENSION / ORAL	AB	RS	2001-07-25	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075671-001	MEGESTROL ACETATE	40MG/ML	SUSPENSION / ORAL	AB	RS	2001-07-25	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A075671-001	MEGESTROL ACETATE	40MG/ML	SUSPENSION / ORAL	AB	RS	2001-07-25	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075671-001	MEGESTROL ACETATE	40MG/ML	SUSPENSION / ORAL	AB	RS	2001-07-25	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075671-001	MEGESTROL ACETATE	40MG/ML	SUSPENSION / ORAL	AB	RS	2001-07-25	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075671-001	MEGESTROL ACETATE	40MG/ML	SUSPENSION / ORAL	AB	RS	2001-07-25	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A075671-001	MEGESTROL ACETATE	40MG/ML	SUSPENSION / ORAL	AB	RS	2001-07-25	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075671-001	MEGESTROL ACETATE	40MG/ML	SUSPENSION / ORAL	AB	RS	2001-07-25	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A075671-001	MEGESTROL ACETATE	40MG/ML	SUSPENSION / ORAL	AB	RS	2001-07-25	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A075671-001	MEGESTROL ACETATE	40MG/ML	SUSPENSION / ORAL	AB	RS	2001-07-25	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A075671-001	MEGESTROL ACETATE	40MG/ML	SUSPENSION / ORAL	AB		2001-07-25	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A075671-001	MEGESTROL ACETATE	40MG/ML	SUSPENSION / ORAL	AB	RS	2001-07-25	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A075671-001	MEGESTROL ACETATE	40MG/ML	SUSPENSION / ORAL	AB	RS	2001-07-25	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A075671-001	MEGESTROL ACETATE	40MG/ML	SUSPENSION / ORAL	AB	RS	2001-07-25	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A075671-001	MEGESTROL ACETATE	40MG/ML	SUSPENSION / ORAL	AB	RS	2001-07-25	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A075671-001	MEGESTROL ACETATE	40MG/ML	SUSPENSION / ORAL	AB	RS	2001-07-25	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A075671-001	MEGESTROL ACETATE	40MG/ML	SUSPENSION / ORAL	AB	RS	2001-07-25	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A075671-001	MEGESTROL ACETATE	40MG/ML	SUSPENSION / ORAL	AB		2001-07-25	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A075671-001	MEGESTROL ACETATE	40MG/ML	SUSPENSION / ORAL	AB		2001-07-25	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A075671-001	MEGESTROL ACETATE	40MG/ML	SUSPENSION / ORAL	AB		2001-07-25	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A075671-001	MEGESTROL ACETATE	40MG/ML	SUSPENSION / ORAL	AB	RS	2001-07-25	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A075671-001	MEGESTROL ACETATE	40MG/ML	SUSPENSION / ORAL	AB	RS	2001-07-25	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A075671-001	MEGESTROL ACETATE	40MG/ML	SUSPENSION / ORAL	AB	RS	2001-07-25	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A075671-001	MEGESTROL ACETATE	40MG/ML	SUSPENSION / ORAL	AB	RS	2001-07-25	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A075671-001	MEGESTROL ACETATE	40MG/ML	SUSPENSION / ORAL	AB	RS	2001-07-25	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A075671-001	MEGESTROL ACETATE	40MG/ML	SUSPENSION / ORAL	AB	RS	2001-07-25	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A075671-001	MEGESTROL ACETATE	40MG/ML	SUSPENSION / ORAL	AB	RS	2001-07-25	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A075671-001	MEGESTROL ACETATE	40MG/ML	SUSPENSION / ORAL	AB	RS	2001-07-25	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A075671-001	MEGESTROL ACETATE	40MG/ML	SUSPENSION / ORAL	AB	RS	2001-07-25	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A075671-001	MEGESTROL ACETATE	40MG/ML	SUSPENSION / ORAL	AB	RS	2001-07-25	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A075671-001	MEGESTROL ACETATE	40MG/ML	SUSPENSION / ORAL	AB	RS	2001-07-25	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A075671-001	MEGESTROL ACETATE	40MG/ML	SUSPENSION / ORAL	AB	RS	2001-07-25	`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	A075671-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A075671-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075671-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075671-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075671-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075671-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075671-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075671-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075671-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075671-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A075671-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075671-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075671-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075671-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A075671-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075671-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A075671-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A075671-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A075671-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A075671-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A075671-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A075671-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A075671-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A075671-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A075671-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A075671-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A075671-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A075671-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A075671-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A075671-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A075671-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A075671-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A075671-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A075671-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A075671-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A075671-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A075671-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A075671-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A075671-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A075671-001	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 · 9 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Megestrol Acetate	MEGESTROL ACETATE	ATLANTIC BIOLOGICALS CORP.	01119031-9943-4afb-8b45-cb71682f0482	2026-07-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075671 application number: ANDA075671 ndc (product): 17856-0060
Megestrol Acetate	MEGESTROL ACETATE	Preferred Pharmaceuticals Inc.	edef65d1-d583-4cee-bb9a-515be84ac51d	2026-06-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075671 application number: ANDA075671
Megestrol Acetate	MEGESTROL ACETATE	Natco Pharma USA LLC	582cff8a-1def-43d6-ba7e-dce49e3e9f27	2026-01-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075671 application number: ANDA075671
Megestrol Acetate	MEGESTROL ACETATE	Kesin Pharma Corporation	3bc8708e-a52d-fda2-e063-6294a90a0fbc	2025-09-02	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075671 application number: ANDA075671
Megestrol Acetate	MEGESTROL ACETATE	PAI Holdings, LLC dba PAI Pharma	46622697-2c51-44d5-9f1f-e48f8526f132	2025-02-07	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075671 application number: ANDA075671 ndc (product): 0121-0945
Megestrol Acetate	MEGESTROL ACETATE	Golden State Medical Supply, Inc.	19c33213-7919-208d-e063-6394a90a0f08	2024-05-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075671 application number: ANDA075671
Megestrol Acetate	MEGESTROL ACETATE	Precision Dose Inc.	bf0d54c5-b813-4f2e-9a37-cbea332cfe53	2024-03-28	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075671 application number: ANDA075671 ndc (product): 68094-174
Megestrol Acetate	MEGESTROL ACETATE	Precision Dose Inc.	d0ad931e-4e3e-48bf-9949-77d6971da6e6	2024-03-28	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075671 application number: ANDA075671 ndc (product): 68094-063
Megestrol Acetate	MEGESTROL ACETATE	Strides Pharma Science Limited	9f7365a0-67cf-45fc-a914-e40a4507a063	2022-04-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075671 application number: ANDA075671 ndc (product): 64380-160

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 31 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0121-0945	Megestrol Acetate	Megestrol Acetate	Pharmaceutical Associates, Inc.	ANDA	Current
0121-0945	Megestrol Acetate	Megestrol Acetate	Pharmaceutical Associates, Inc.	ANDA	Current
0904-7072	Megestrol Acetate	Megestrol Acetate	Major Pharmaceuticals	ANDA	Current
0904-7072	Megestrol Acetate	Megestrol Acetate	Major Pharmaceuticals	ANDA	Current
17856-0060	Megestrol Acetate	Megestrol Acetate	ATLANTIC BIOLOGICALS CORP.	ANDA	Current
17856-0907	Megestrol Acetate	Megestrol Acetate	Atlantic Biologicals Corps	ANDA	Current
17856-0907	Megestrol Acetate	Megestrol Acetate	Atlantic Biologicals Corps	ANDA	Current
17856-0907	Megestrol Acetate	Megestrol Acetate	Atlantic Biologicals Corps	ANDA	Current
17856-0907	Megestrol Acetate	Megestrol Acetate	ATLANTIC BIOLOGICALS CORP.	ANDA	Current
33358-903	Megestrol Acetate	Megestrol Acetate	Rxchange Co	ANDA	Current
49884-907	Megestrol Acetate	Megestrol Acetate	Par Pharmaceutical, Inc.	ANDA	Current
49884-907	Megestrol Acetate	Megestrol Acetate	Par Pharmaceutical, Inc.	ANDA	Current
49884-907	Megestrol Acetate	Megestrol Acetate	Par Pharmaceutical, Inc.	ANDA	Current
49884-907	Megestrol Acetate	Megestrol Acetate	Par Pharmaceutical, Inc.	ANDA	Current
63739-549	Megestrol Acetate	Megestrol Acetate	McKesson Corporation dba SKY Packaging	ANDA	Current
63739-549	Megestrol Acetate	Megestrol Acetate	McKesson Corporation	ANDA	Current
63739-549	Megestrol Acetate	Megestrol Acetate	McKesson Corporation DBA SKY Packaging	ANDA	Current
64380-160	Megestrol Acetate	Megestrol Acetate	Strides Pharma Science Limited	ANDA	Current
64380-160	Megestrol Acetate	Megestrol Acetate	Strides Pharma Science Limited	ANDA	Current
66689-020	Megestrol Acetate	Megestrol Acetate	VistaPharm, Inc.	ANDA	Current
66689-020	Megestrol Acetate	Megestrol Acetate	VistaPharm, Inc.	ANDA	Current
66689-020	Megestrol Acetate	Megestrol Acetate	VistaPharm, Inc.	ANDA	Current
66689-020	Megestrol Acetate	Megestrol Acetate	VistaPharm, Inc.	ANDA	Current
68094-063	Megestrol Acetate	Megestrol Acetate	Precision Dose Inc.	ANDA	Current
68094-174	Megestrol Acetate	Megestrol Acetate	Precision Dose Inc.	ANDA	Current
68094-250	Megestrol Acetate	Megestrol Acetate	Precision Dose Inc.	ANDA	Current
68094-250	Megestrol Acetate	Megestrol Acetate	Precision Dose Inc.	ANDA	Current
68094-361	Megestrol Acetate	Megestrol Acetate	Precision Dose Inc.	ANDA	Current
68094-361	Megestrol Acetate	Megestrol Acetate	Precision Dose Inc.	ANDA	Current
68094-361	Megestrol Acetate	Megestrol Acetate	Precision Dose Inc.	ANDA	Current
81646-120	Megestrol Acetate	Megestrol Acetate	PINNACLE PHARMA LLC	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
30984	ORIG	2004-06-09
22494	ORIG	2002-01-17
8759	ORIG	2001-07-25