Application 204823

Type: ANDA
Sponsor: ANDA REPOSITORY

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	CYPROHEPTADINE HYDROCHLORIDE	CYPROHEPTADINE HYDROCHLORIDE	SYRUP;ORAL	2MG/5ML	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
A204823-001	CYPROHEPTADINE HYDROCHLORIDE	CYPROHEPTADINE HYDROCHLORIDE	2MG/5ML	SYRUP / ORAL			2016-12-27

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 · 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	A204823-001	CYPROHEPTADINE HYDROCHLORIDE	2MG/5ML	SYRUP / ORAL		2016-12-27	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204823-001	CYPROHEPTADINE HYDROCHLORIDE	2MG/5ML	SYRUP / ORAL		2016-12-27	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A204823-001	CYPROHEPTADINE HYDROCHLORIDE	2MG/5ML	SYRUP / ORAL		2016-12-27	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204823-001	CYPROHEPTADINE HYDROCHLORIDE	2MG/5ML	SYRUP / ORAL		2016-12-27	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204823-001	CYPROHEPTADINE HYDROCHLORIDE	2MG/5ML	SYRUP / ORAL		2016-12-27	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204823-001	CYPROHEPTADINE HYDROCHLORIDE	2MG/5ML	SYRUP / ORAL		2016-12-27	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204823-001	CYPROHEPTADINE HYDROCHLORIDE	2MG/5ML	SYRUP / ORAL		2016-12-27	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204823-001	CYPROHEPTADINE HYDROCHLORIDE	2MG/5ML	SYRUP / ORAL		2016-12-27	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204823-001	CYPROHEPTADINE HYDROCHLORIDE	2MG/5ML	SYRUP / ORAL		2016-12-27	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A204823-001	CYPROHEPTADINE HYDROCHLORIDE	2MG/5ML	SYRUP / ORAL		2016-12-27	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204823-001	CYPROHEPTADINE HYDROCHLORIDE	2MG/5ML	SYRUP / ORAL		2016-12-27	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204823-001	CYPROHEPTADINE HYDROCHLORIDE	2MG/5ML	SYRUP / ORAL		2016-12-27	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A204823-001	CYPROHEPTADINE HYDROCHLORIDE	2MG/5ML	SYRUP / ORAL		2016-12-27	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A204823-001	CYPROHEPTADINE HYDROCHLORIDE	2MG/5ML	SYRUP / ORAL		2016-12-27	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A204823-001	CYPROHEPTADINE HYDROCHLORIDE	2MG/5ML	SYRUP / ORAL	AA	2016-12-27	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A204823-001	CYPROHEPTADINE HYDROCHLORIDE	2MG/5ML	SYRUP / ORAL	AA	2016-12-27	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A204823-001	CYPROHEPTADINE HYDROCHLORIDE	2MG/5ML	SYRUP / ORAL	AA	2016-12-27	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A204823-001	CYPROHEPTADINE HYDROCHLORIDE	2MG/5ML	SYRUP / ORAL	AA	2016-12-27	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A204823-001	CYPROHEPTADINE HYDROCHLORIDE	2MG/5ML	SYRUP / ORAL	AA	2016-12-27	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A204823-001	CYPROHEPTADINE HYDROCHLORIDE	2MG/5ML	SYRUP / ORAL	AA	2016-12-27	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A204823-001	CYPROHEPTADINE HYDROCHLORIDE	2MG/5ML	SYRUP / ORAL	AA	2016-12-27	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A204823-001	CYPROHEPTADINE HYDROCHLORIDE	2MG/5ML	SYRUP / ORAL	AA	2016-12-27	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A204823-001	CYPROHEPTADINE HYDROCHLORIDE	2MG/5ML	SYRUP / ORAL	AA	2016-12-27	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A204823-001	CYPROHEPTADINE HYDROCHLORIDE	2MG/5ML	SYRUP / ORAL	AA	2016-12-27	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A204823-001	CYPROHEPTADINE HYDROCHLORIDE	2MG/5ML	SYRUP / ORAL	AA	2016-12-27	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A204823-001	CYPROHEPTADINE HYDROCHLORIDE	2MG/5ML	SYRUP / ORAL	AA	2016-12-27	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A204823-001	CYPROHEPTADINE HYDROCHLORIDE	2MG/5ML	SYRUP / ORAL	AA	2016-12-27	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A204823-001	CYPROHEPTADINE HYDROCHLORIDE	2MG/5ML	SYRUP / ORAL	AA	2016-12-27	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A204823-001	CYPROHEPTADINE HYDROCHLORIDE	2MG/5ML	SYRUP / ORAL	AA	2016-12-27	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A204823-001	CYPROHEPTADINE HYDROCHLORIDE	2MG/5ML	SYRUP / ORAL	AA	2016-12-27	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A204823-001	CYPROHEPTADINE HYDROCHLORIDE	2MG/5ML	SYRUP / ORAL	AA	2016-12-27	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A204823-001	CYPROHEPTADINE HYDROCHLORIDE	2MG/5ML	SYRUP / ORAL	AA	2016-12-27	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A204823-001	CYPROHEPTADINE HYDROCHLORIDE	2MG/5ML	SYRUP / ORAL	AA	2016-12-27	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A204823-001	CYPROHEPTADINE HYDROCHLORIDE	2MG/5ML	SYRUP / ORAL	AA	2016-12-27	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A204823-001	CYPROHEPTADINE HYDROCHLORIDE	2MG/5ML	SYRUP / ORAL	AA	2016-12-27	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A204823-001	CYPROHEPTADINE HYDROCHLORIDE	2MG/5ML	SYRUP / ORAL	AA	2016-12-27	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A204823-001	CYPROHEPTADINE HYDROCHLORIDE	2MG/5ML	SYRUP / ORAL	AA	2016-12-27	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A204823-001	CYPROHEPTADINE HYDROCHLORIDE	2MG/5ML	SYRUP / ORAL	AA	2016-12-27	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A204823-001	CYPROHEPTADINE HYDROCHLORIDE	2MG/5ML	SYRUP / ORAL	AA	2016-12-27	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A204823-001	CYPROHEPTADINE HYDROCHLORIDE	2MG/5ML	SYRUP / ORAL	AA	2016-12-27	`cb3db0bc1861…`

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	A204823-001	AA	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A204823-001	AA	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A204823-001	AA	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A204823-001	AA	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A204823-001	AA	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A204823-001	AA	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A204823-001	AA	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A204823-001	AA	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A204823-001	AA	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A204823-001	AA	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A204823-001	AA	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A204823-001	AA	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A204823-001	AA	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A204823-001	AA	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A204823-001	AA	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A204823-001	AA	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A204823-001	AA	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A204823-001	AA	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A204823-001	AA	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A204823-001	AA	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A204823-001	AA	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A204823-001	AA	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A204823-001	AA	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A204823-001	AA	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A204823-001	AA	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A204823-001	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 2 · 33 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Cyproheptadine Hydrochloride	CYPROHEPTADINE HYDROCHLORIDE	TRUPHARMA, LLC	1d668d93-8c9e-479e-ad8d-59656c8dec1b	2026-07-14	Warnings, Adverse reactions	Name fallback brand name: Cyproheptadine Hydrochloride generic name: CYPROHEPTADINE HYDROCHLORIDE
Cyproheptadine Hydrochloride	CYPROHEPTADINE HYDROCHLORIDE	REMEDYREPACK INC.	80411af3-03ee-4330-830b-f69f2a373ef9	2026-06-01	Warnings, Adverse reactions	Name fallback brand name: Cyproheptadine Hydrochloride generic name: CYPROHEPTADINE HYDROCHLORIDE
Cyproheptadine Hydrochloride	CYPROHEPTADINE HYDROCHLORIDE	Atlantic Biological Corp.	50b3abc0-d86a-e8f5-e063-6394a90ad25e	2026-04-30	Warnings, Adverse reactions	Name fallback brand name: Cyproheptadine Hydrochloride generic name: CYPROHEPTADINE HYDROCHLORIDE
CYPROHEPTADINE HYDROCHLORIDE	CYPROHEPTADINE HYDROCHLORIDE	REMEDYREPACK INC.	7b3aed50-cc9e-4897-9735-361225e9e5f2	2026-04-10	Warnings, Adverse reactions	Name fallback brand name: CYPROHEPTADINE HYDROCHLORIDE generic name: CYPROHEPTADINE HYDROCHLORIDE
CYPROHEPTADINE HYDROCHLORIDE	CYPROHEPTADINE HYDROCHLORIDE	Strides Pharma Science Limited	b28c2ca0-140d-44d8-a59e-75fbfe8eabdd	2026-03-06	Warnings, Adverse reactions	Name fallback brand name: CYPROHEPTADINE HYDROCHLORIDE generic name: CYPROHEPTADINE HYDROCHLORIDE
Cyproheptadine Hydrochloride	CYPROHEPTADINE HYDROCHLORIDE	PD-Rx Pharmaceuticals, Inc.	03e69414-8a25-4ed8-b7ac-16445b879b1f	2026-02-16	Warnings, Adverse reactions	Name fallback brand name: Cyproheptadine Hydrochloride generic name: CYPROHEPTADINE HYDROCHLORIDE
Cyproheptadine Hydrochloride	CYPROHEPTADINE HYDROCHLORIDE	UNICHEM PHARMACEUTICALS (USA), INC.	99fb821a-fe33-4468-9026-9729a8deff08	2026-01-22	Warnings, Adverse reactions	Name fallback brand name: Cyproheptadine Hydrochloride generic name: CYPROHEPTADINE HYDROCHLORIDE
Cyproheptadine Hydrochloride	CYPROHEPTADINE HYDROCHLORIDE	Amneal Pharmaceuticals of New York LLC	80e13d3f-f4db-4bb4-95d5-5ac1afa70e7e	2025-12-22	Warnings, Adverse reactions	Name fallback brand name: Cyproheptadine Hydrochloride generic name: CYPROHEPTADINE HYDROCHLORIDE
Cyproheptadine Hydrochloride	CYPROHEPTADINE HYDROCHLORIDE	QPharma Inc	fc75bd79-63b7-6388-e053-6394a90ac377	2025-12-02	Warnings, Adverse reactions	Name fallback brand name: Cyproheptadine Hydrochloride generic name: CYPROHEPTADINE HYDROCHLORIDE
CYPROHEPTADINE HYDROCHLORIDE	CYPROHEPTADINE HYDROCHLORIDE	QPharma Inc	1dfe4478-76d9-9b8f-e063-6394a90aefe8	2025-12-01	Warnings, Adverse reactions	Name fallback brand name: CYPROHEPTADINE HYDROCHLORIDE generic name: CYPROHEPTADINE HYDROCHLORIDE
CYPROHEPTADINE HYDROCHLORIDE	CYPROHEPTADINE HYDROCHLORIDE	Bryant Ranch Prepack	22eaef18-b5cc-421a-910e-d569f00b4599	2025-11-10	Warnings, Adverse reactions	Name fallback brand name: CYPROHEPTADINE HYDROCHLORIDE generic name: CYPROHEPTADINE HYDROCHLORIDE
Cyproheptadine Hydrochloride	CYPROHEPTADINE HYDROCHLORIDE	AvPAK	426acecc-aef4-099c-e063-6294a90a54eb	2025-10-30	Warnings, Adverse reactions	Name fallback brand name: Cyproheptadine Hydrochloride generic name: CYPROHEPTADINE HYDROCHLORIDE
cyproheptadine hydrochloride solution	CYPROHEPTADINE HYDROCHLORIDE	Method Pharmaceuticals, LLC	1acfd050-6c07-a269-e063-6394a90a77e8	2025-10-21	Warnings, Adverse reactions	Name fallback generic name: CYPROHEPTADINE HYDROCHLORIDE
CYPROHEPTADINE HYDROCHLORIDE	CYPROHEPTADINE HYDROCHLORIDE	Golden State Medical Supply, Inc.	95c03949-0e9a-e3b5-e053-2995a90a56b6	2025-08-06	Warnings, Adverse reactions	Name fallback brand name: CYPROHEPTADINE HYDROCHLORIDE generic name: CYPROHEPTADINE HYDROCHLORIDE
CYPROHEPTADINE HYDROCHLORIDE	CYPROHEPTADINE HYDROCHLORIDE	Bryant Ranch Prepack	996dd4c6-ebcf-42e8-a950-9d34bb6f404f	2025-05-05	Warnings, Adverse reactions	Name fallback brand name: CYPROHEPTADINE HYDROCHLORIDE generic name: CYPROHEPTADINE HYDROCHLORIDE
Cyproheptadine Hydrochloride	CYPROHEPTADINE HYDROCHLORIDE	Rising Pharma Holdings, Inc.	e2bf4d46-6585-41d9-868c-98603b165d5b	2025-03-26	Warnings, Adverse reactions	Name fallback brand name: Cyproheptadine Hydrochloride generic name: CYPROHEPTADINE HYDROCHLORIDE
CYPROHEPTADINE HYDROCHLORIDE	CYPROHEPTADINE HYDROCHLORIDE	Ingenus Pharmaceuticals LLC	56f428c9-8d33-4c91-91d8-1fe194335066	2025-01-01	Warnings, Adverse reactions	Name fallback brand name: CYPROHEPTADINE HYDROCHLORIDE generic name: CYPROHEPTADINE HYDROCHLORIDE
CYPROHEPTADINE HYDROCHLORIDE	CYPROHEPTADINE HYDROCHLORIDE	Zydus Lifesciences Limited	ccd7d3b2-b0c1-4f66-8d06-d21f5cfa8c1e	2024-11-26		Name fallback brand name: CYPROHEPTADINE HYDROCHLORIDE generic name: CYPROHEPTADINE HYDROCHLORIDE
CYPROHEPTADINE HYDROCHLORIDE	CYPROHEPTADINE HYDROCHLORIDE	Bryant Ranch Prepack	5d0db096-f35d-4065-bff1-2fd7ef5a1a6f	2024-08-20	Warnings, Adverse reactions	Name fallback brand name: CYPROHEPTADINE HYDROCHLORIDE generic name: CYPROHEPTADINE HYDROCHLORIDE
CYPROHEPTADINE HYDROCHLORIDE	CYPROHEPTADINE HYDROCHLORIDE	QUAGEN PHARMACEUTICALS LLC	d3ce21de-849a-47ab-8405-968d8de6f1e9	2024-06-15	Warnings, Adverse reactions	Name fallback brand name: CYPROHEPTADINE HYDROCHLORIDE generic name: CYPROHEPTADINE HYDROCHLORIDE

NDC Listings For This Application#

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

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
39328-044	Cyproheptadine Hydrochloride	Cyproheptadine Hydrochloride	Patrin Pharma	ANDA	Current