Application 203960

Type: ANDA
Sponsor: HI TECH

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	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

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
A203960-001	MEGESTROL ACETATE	MEGESTROL ACETATE	40MG/ML	SUSPENSION / ORAL			2017-06-09

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 · 44 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-10-15 13:18:30	2026-09	A203960-001	MEGESTROL ACETATE	40MG/ML	SUSPENSION / ORAL		2017-06-09	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A203960-001	MEGESTROL ACETATE	40MG/ML	SUSPENSION / ORAL		2017-06-09	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A203960-001	MEGESTROL ACETATE	40MG/ML	SUSPENSION / ORAL		2017-06-09	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A203960-001	MEGESTROL ACETATE	40MG/ML	SUSPENSION / ORAL		2017-06-09	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203960-001	MEGESTROL ACETATE	40MG/ML	SUSPENSION / ORAL		2017-06-09	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A203960-001	MEGESTROL ACETATE	40MG/ML	SUSPENSION / ORAL		2017-06-09	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203960-001	MEGESTROL ACETATE	40MG/ML	SUSPENSION / ORAL		2017-06-09	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203960-001	MEGESTROL ACETATE	40MG/ML	SUSPENSION / ORAL		2017-06-09	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203960-001	MEGESTROL ACETATE	40MG/ML	SUSPENSION / ORAL		2017-06-09	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203960-001	MEGESTROL ACETATE	40MG/ML	SUSPENSION / ORAL		2017-06-09	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203960-001	MEGESTROL ACETATE	40MG/ML	SUSPENSION / ORAL		2017-06-09	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203960-001	MEGESTROL ACETATE	40MG/ML	SUSPENSION / ORAL		2017-06-09	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A203960-001	MEGESTROL ACETATE	40MG/ML	SUSPENSION / ORAL		2017-06-09	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203960-001	MEGESTROL ACETATE	40MG/ML	SUSPENSION / ORAL		2017-06-09	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203960-001	MEGESTROL ACETATE	40MG/ML	SUSPENSION / ORAL		2017-06-09	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203960-001	MEGESTROL ACETATE	40MG/ML	SUSPENSION / ORAL		2017-06-09	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A203960-001	MEGESTROL ACETATE	40MG/ML	SUSPENSION / ORAL		2017-06-09	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A203960-001	MEGESTROL ACETATE	40MG/ML	SUSPENSION / ORAL	AB	2017-06-09	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A203960-001	MEGESTROL ACETATE	40MG/ML	SUSPENSION / ORAL	AB	2017-06-09	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A203960-001	MEGESTROL ACETATE	40MG/ML	SUSPENSION / ORAL	AB	2017-06-09	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A203960-001	MEGESTROL ACETATE	40MG/ML	SUSPENSION / ORAL	AB	2017-06-09	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A203960-001	MEGESTROL ACETATE	40MG/ML	SUSPENSION / ORAL	AB	2017-06-09	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A203960-001	MEGESTROL ACETATE	40MG/ML	SUSPENSION / ORAL	AB	2017-06-09	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A203960-001	MEGESTROL ACETATE	40MG/ML	SUSPENSION / ORAL	AB	2017-06-09	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A203960-001	MEGESTROL ACETATE	40MG/ML	SUSPENSION / ORAL	AB	2017-06-09	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A203960-001	MEGESTROL ACETATE	40MG/ML	SUSPENSION / ORAL	AB	2017-06-09	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A203960-001	MEGESTROL ACETATE	40MG/ML	SUSPENSION / ORAL	AB	2017-06-09	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A203960-001	MEGESTROL ACETATE	40MG/ML	SUSPENSION / ORAL	AB	2017-06-09	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A203960-001	MEGESTROL ACETATE	40MG/ML	SUSPENSION / ORAL	AB	2017-06-09	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A203960-001	MEGESTROL ACETATE	40MG/ML	SUSPENSION / ORAL	AB	2017-06-09	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A203960-001	MEGESTROL ACETATE	40MG/ML	SUSPENSION / ORAL	AB	2017-06-09	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A203960-001	MEGESTROL ACETATE	40MG/ML	SUSPENSION / ORAL	AB	2017-06-09	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A203960-001	MEGESTROL ACETATE	40MG/ML	SUSPENSION / ORAL	AB	2017-06-09	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A203960-001	MEGESTROL ACETATE	40MG/ML	SUSPENSION / ORAL	AB	2017-06-09	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A203960-001	MEGESTROL ACETATE	40MG/ML	SUSPENSION / ORAL	AB	2017-06-09	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A203960-001	MEGESTROL ACETATE	40MG/ML	SUSPENSION / ORAL	AB	2017-06-09	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A203960-001	MEGESTROL ACETATE	40MG/ML	SUSPENSION / ORAL	AB	2017-06-09	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A203960-001	MEGESTROL ACETATE	40MG/ML	SUSPENSION / ORAL	AB	2017-06-09	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A203960-001	MEGESTROL ACETATE	40MG/ML	SUSPENSION / ORAL	AB	2017-06-09	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A203960-001	MEGESTROL ACETATE	40MG/ML	SUSPENSION / ORAL	AB	2017-06-09	`3a93d1ddd44b…`

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	A203960-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A203960-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A203960-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A203960-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A203960-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A203960-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A203960-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A203960-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A203960-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A203960-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A203960-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A203960-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A203960-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A203960-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A203960-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A203960-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A203960-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A203960-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A203960-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A203960-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A203960-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A203960-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A203960-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A203960-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A203960-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A203960-001	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 · 20 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	Name fallback brand name: Megestrol Acetate generic name: MEGESTROL ACETATE
Megestrol Acetate	MEGESTROL ACETATE	Preferred Pharmaceuticals Inc.	edef65d1-d583-4cee-bb9a-515be84ac51d	2026-06-15	Warnings, Adverse reactions	Name fallback brand name: Megestrol Acetate generic name: MEGESTROL ACETATE
Megestrol Acetate	MEGESTROL ACETATE	Upsher-Smith Laboratories, LLC	2dc921d5-e423-4379-a345-151e87d13651	2026-04-14	Warnings, Adverse reactions	Name fallback brand name: Megestrol Acetate generic name: MEGESTROL ACETATE
Megestrol Acetate	MEGESTROL ACETATE	Major Pharmaceuticals	e44cf173-991b-43cf-93f2-e0efaa4cc29a	2026-01-15	Warnings, Adverse reactions	Name fallback brand name: Megestrol Acetate generic name: MEGESTROL ACETATE
Megestrol Acetate	MEGESTROL ACETATE	Natco Pharma USA LLC	582cff8a-1def-43d6-ba7e-dce49e3e9f27	2026-01-15	Warnings, Adverse reactions	Name fallback brand name: Megestrol Acetate generic name: MEGESTROL ACETATE
Megestrol Acetate	MEGESTROL ACETATE	American Health Packaging	2921731a-6866-4dc8-8f6b-b636abf7bcf8	2026-01-05	Warnings, Adverse reactions	Name fallback brand name: Megestrol Acetate generic name: MEGESTROL ACETATE
Megestrol Acetate	MEGESTROL ACETATE	PAI Holdings, LLC dba PAI Pharma	2d5b58cd-cbb1-4f5c-b13f-63185c0f8e31	2025-10-17	Warnings, Adverse reactions	Name fallback brand name: Megestrol Acetate generic name: MEGESTROL ACETATE
Megestrol Acetate	MEGESTROL ACETATE	Major Pharmaceuticals	2c755c6b-32e9-4029-8b70-855007f7375b	2025-09-15	Warnings, Adverse reactions	Name fallback brand name: Megestrol Acetate generic name: MEGESTROL ACETATE
Megestrol Acetate	MEGESTROL ACETATE	Kesin Pharma Corporation	3bc8708e-a52d-fda2-e063-6294a90a0fbc	2025-09-02	Warnings, Adverse reactions	Name fallback brand name: Megestrol Acetate generic name: MEGESTROL ACETATE
Megestrol Acetate	MEGESTROL ACETATE	Xttrium Laboratories, Inc.	3169f883-4076-32ce-e063-6394a90a4925	2025-07-24	Warnings, Adverse reactions	Name fallback brand name: Megestrol Acetate generic name: MEGESTROL ACETATE
Megestrol Acetate	MEGESTROL ACETATE	Bryant Ranch Prepack	dd6617df-0876-4fc5-8435-b53d29ccc1ae	2025-03-31	Warnings, Adverse reactions	Name fallback brand name: Megestrol Acetate generic name: MEGESTROL ACETATE
Megestrol Acetate	MEGESTROL ACETATE	Strides Pharma Science Limited	8ec70070-da70-4a38-9d58-cf2278517661	2025-02-24	Warnings, Adverse reactions	Name fallback brand name: Megestrol Acetate generic name: MEGESTROL ACETATE
Megestrol Acetate	MEGESTROL ACETATE	Bryant Ranch Prepack	9b764cf3-4756-4f0e-b747-421d71674313	2025-01-17	Warnings, Adverse reactions	Name fallback brand name: Megestrol Acetate generic name: MEGESTROL ACETATE
Megestrol Acetate	MEGESTROL ACETATE	Golden State Medical Supply, Inc.	19c33213-7919-208d-e063-6394a90a0f08	2024-05-31	Warnings, Adverse reactions	Name fallback brand name: Megestrol Acetate generic name: MEGESTROL ACETATE
Megestrol Acetate	MEGESTROL ACETATE	Precision Dose Inc.	bf0d54c5-b813-4f2e-9a37-cbea332cfe53	2024-03-28	Warnings, Adverse reactions	Name fallback brand name: Megestrol Acetate generic name: MEGESTROL ACETATE
Megestrol Acetate	MEGESTROL ACETATE	Precision Dose Inc.	d0ad931e-4e3e-48bf-9949-77d6971da6e6	2024-03-28	Warnings, Adverse reactions	Name fallback brand name: Megestrol Acetate generic name: MEGESTROL ACETATE
Megestrol Acetate	MEGESTROL ACETATE	ANI Pharmaceuticals, Inc.	a26dcd78-ad62-4cf5-ad97-49ccb34d43ba	2024-03-20	Warnings, Adverse reactions	Name fallback brand name: Megestrol Acetate generic name: MEGESTROL ACETATE
Megestrol Acetate	MEGESTROL ACETATE	Teva Pharmaceuticals USA, Inc.	66573d39-f2a7-49fd-9ed2-97ac8f6e8456	2022-11-30	Warnings, Adverse reactions	Name fallback brand name: Megestrol Acetate generic name: MEGESTROL ACETATE
Megestrol Acetate	MEGESTROL ACETATE	Strides Pharma Science Limited	9f7365a0-67cf-45fc-a914-e40a4507a063	2022-04-22	Warnings, Adverse reactions	Name fallback brand name: Megestrol Acetate generic name: MEGESTROL ACETATE
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.

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 7 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
50383-859	Megestrol Acetate	Megestrol Acetate	Hi-Tech Pharmacal Co., Inc.	ANDA	Current
50383-859	Megestrol Acetate	Megestrol Acetate	Hi-Tech Pharmacal Co., Inc.	ANDA	Current
50383-859	Megestrol Acetate	Megestrol Acetate	Hi-Tech Pharmacal Co., Inc.	ANDA	Current
50383-859	Megestrol Acetate	Megestrol Acetate	Akorn	ANDA	Current
50383-859	Megestrol Acetate	Megestrol Acetate	Hi-Tech Pharmacal Co., Inc.	ANDA	Current
50383-859	Megestrol Acetate	Megestrol Acetate	Akorn	ANDA	Current
50383-859	Megestrol Acetate	Megestrol Acetate	Akorn	ANDA	Current