Application 040537

Type: ANDA
Sponsor: MOUNTAIN

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	CYPROHEPTADINE HYDROCHLORIDE	CYPROHEPTADINE HYDROCHLORIDE	TABLET;ORAL	4MG	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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
A040537-001	CYPROHEPTADINE HYDROCHLORIDE	CYPROHEPTADINE HYDROCHLORIDE	4MG	TABLET / ORAL	AA		2003-09-30

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A040537-001	AA

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 · 41 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
2026-02-19 14:30 UTC	2026-02	A040537-001	CYPROHEPTADINE HYDROCHLORIDE	4MG	TABLET / ORAL	AA	2003-09-30	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040537-001	CYPROHEPTADINE HYDROCHLORIDE	4MG	TABLET / ORAL	AA	2003-09-30	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A040537-001	CYPROHEPTADINE HYDROCHLORIDE	4MG	TABLET / ORAL	AA	2003-09-30	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040537-001	CYPROHEPTADINE HYDROCHLORIDE	4MG	TABLET / ORAL	AA	2003-09-30	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040537-001	CYPROHEPTADINE HYDROCHLORIDE	4MG	TABLET / ORAL	AA	2003-09-30	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040537-001	CYPROHEPTADINE HYDROCHLORIDE	4MG	TABLET / ORAL	AA	2003-09-30	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040537-001	CYPROHEPTADINE HYDROCHLORIDE	4MG	TABLET / ORAL	AA	2003-09-30	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040537-001	CYPROHEPTADINE HYDROCHLORIDE	4MG	TABLET / ORAL	AA	2003-09-30	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040537-001	CYPROHEPTADINE HYDROCHLORIDE	4MG	TABLET / ORAL	AA	2003-09-30	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A040537-001	CYPROHEPTADINE HYDROCHLORIDE	4MG	TABLET / ORAL	AA	2003-09-30	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040537-001	CYPROHEPTADINE HYDROCHLORIDE	4MG	TABLET / ORAL	AA	2003-09-30	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040537-001	CYPROHEPTADINE HYDROCHLORIDE	4MG	TABLET / ORAL	AA	2003-09-30	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040537-001	CYPROHEPTADINE HYDROCHLORIDE	4MG	TABLET / ORAL	AA	2003-09-30	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A040537-001	CYPROHEPTADINE HYDROCHLORIDE	4MG	TABLET / ORAL	AA	2003-09-30	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A040537-001	CYPROHEPTADINE HYDROCHLORIDE	4MG	TABLET / ORAL	AA	2003-09-30	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A040537-001	CYPROHEPTADINE HYDROCHLORIDE	4MG	TABLET / ORAL	AA	2003-09-30	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A040537-001	CYPROHEPTADINE HYDROCHLORIDE	4MG	TABLET / ORAL	AA	2003-09-30	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A040537-001	CYPROHEPTADINE HYDROCHLORIDE	4MG	TABLET / ORAL	AA	2003-09-30	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A040537-001	CYPROHEPTADINE HYDROCHLORIDE	4MG	TABLET / ORAL	AA	2003-09-30	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A040537-001	CYPROHEPTADINE HYDROCHLORIDE	4MG	TABLET / ORAL	AA	2003-09-30	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A040537-001	CYPROHEPTADINE HYDROCHLORIDE	4MG	TABLET / ORAL	AA	2003-09-30	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A040537-001	CYPROHEPTADINE HYDROCHLORIDE	4MG	TABLET / ORAL	AA	2003-09-30	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A040537-001	CYPROHEPTADINE HYDROCHLORIDE	4MG	TABLET / ORAL	AA	2003-09-30	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A040537-001	CYPROHEPTADINE HYDROCHLORIDE	4MG	TABLET / ORAL	AA	2003-09-30	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A040537-001	CYPROHEPTADINE HYDROCHLORIDE	4MG	TABLET / ORAL	AA	2003-09-30	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A040537-001	CYPROHEPTADINE HYDROCHLORIDE	4MG	TABLET / ORAL	AA	2003-09-30	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A040537-001	CYPROHEPTADINE HYDROCHLORIDE	4MG	TABLET / ORAL	AA	2003-09-30	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A040537-001	CYPROHEPTADINE HYDROCHLORIDE	4MG	TABLET / ORAL	AA	2003-09-30	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A040537-001	CYPROHEPTADINE HYDROCHLORIDE	4MG	TABLET / ORAL	AA	2003-09-30	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A040537-001	CYPROHEPTADINE HYDROCHLORIDE	4MG	TABLET / ORAL	AA	2003-09-30	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A040537-001	CYPROHEPTADINE HYDROCHLORIDE	4MG	TABLET / ORAL	AA	2003-09-30	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A040537-001	CYPROHEPTADINE HYDROCHLORIDE	4MG	TABLET / ORAL	AA	2003-09-30	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A040537-001	CYPROHEPTADINE HYDROCHLORIDE	4MG	TABLET / ORAL	AA	2003-09-30	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A040537-001	CYPROHEPTADINE HYDROCHLORIDE	4MG	TABLET / ORAL	AA	2003-09-30	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A040537-001	CYPROHEPTADINE HYDROCHLORIDE	4MG	TABLET / ORAL	AA	2003-09-30	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A040537-001	CYPROHEPTADINE HYDROCHLORIDE	4MG	TABLET / ORAL	AA	2003-09-30	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A040537-001	CYPROHEPTADINE HYDROCHLORIDE	4MG	TABLET / ORAL	AA	2003-09-30	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A040537-001	CYPROHEPTADINE HYDROCHLORIDE	4MG	TABLET / ORAL	AA	2003-09-30	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A040537-001	CYPROHEPTADINE HYDROCHLORIDE	4MG	TABLET / ORAL	AA	2003-09-30	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A040537-001	CYPROHEPTADINE HYDROCHLORIDE	4MG	TABLET / ORAL	AA	2003-09-30	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A040537-001	AA	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040537-001	AA	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A040537-001	AA	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040537-001	AA	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040537-001	AA	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040537-001	AA	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040537-001	AA	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040537-001	AA	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040537-001	AA	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A040537-001	AA	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040537-001	AA	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040537-001	AA	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040537-001	AA	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A040537-001	AA	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A040537-001	AA	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A040537-001	AA	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A040537-001	AA	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A040537-001	AA	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A040537-001	AA	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A040537-001	AA	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A040537-001	AA	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A040537-001	AA	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A040537-001	AA	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A040537-001	AA	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A040537-001	AA	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A040537-001	AA	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A040537-001	AA	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A040537-001	AA	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A040537-001	AA	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A040537-001	AA	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A040537-001	AA	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A040537-001	AA	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A040537-001	AA	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A040537-001	AA	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A040537-001	AA	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A040537-001	AA	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A040537-001	AA	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A040537-001	AA	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A040537-001	AA	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A040537-001	AA	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 · 4 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Cyproheptadine Hydrochloride	CYPROHEPTADINE HYDROCHLORIDE	REMEDYREPACK INC.	80411af3-03ee-4330-830b-f69f2a373ef9	2026-06-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040537 application number: ANDA040537
Cyproheptadine Hydrochloride	CYPROHEPTADINE HYDROCHLORIDE	Amneal Pharmaceuticals of New York LLC	80e13d3f-f4db-4bb4-95d5-5ac1afa70e7e	2025-12-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040537 application number: ANDA040537 ndc (product): 0115-1757
Cyproheptadine Hydrochloride	CYPROHEPTADINE HYDROCHLORIDE	AvPAK	426acecc-aef4-099c-e063-6294a90a54eb	2025-10-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040537 application number: ANDA040537
Cyproheptadine Hydrochloride	CYPROHEPTADINE HYDROCHLORIDE	Bryant Ranch Prepack	6a5b5a89-82c2-4991-b026-d160d8fa59a3	2024-05-23	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040537 application number: ANDA040537

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
0115-1757	Cyproheptadine Hydrochloride	Cyproheptadine Hydrochloride	Amneal Pharmaceuticals of New York LLC	ANDA	Current
0115-1757	Cyproheptadine Hydrochloride	Cyproheptadine Hydrochloride	Amneal Pharmaceuticals of New York LLC	ANDA	Current
0115-1757	Cyproheptadine Hydrochloride	Cyproheptadine Hydrochloride	Impax Generics	ANDA	Current
0115-1757	Cyproheptadine Hydrochloride	Cyproheptadine Hydrochloride	Amneal Pharmaceuticals of New York LLC	ANDA	Current
53808-0950	CYPROHEPTADINE HYDROCHLORIDE	CYPROHEPTADINE HYDROCHLORIDE	State of Florida DOH Central Pharmacy	ANDA	Current
64720-150	Cyproheptadine Hydrochloride	Cyproheptadine Hydrochloride	CorePharma, LLC	ANDA	Current
64720-150	Cyproheptadine Hydrochloride	Cyproheptadine Hydrochloride	CorePharma, LLC	ANDA	Current