Application 091295

Type: ANDA
Sponsor: PHARM ASSOC

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
A091295-001	CYPROHEPTADINE HYDROCHLORIDE	CYPROHEPTADINE HYDROCHLORIDE	2MG/5ML	SYRUP / ORAL			2013-03-28

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	A091295-001	CYPROHEPTADINE HYDROCHLORIDE	2MG/5ML	SYRUP / ORAL		2013-03-28	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091295-001	CYPROHEPTADINE HYDROCHLORIDE	2MG/5ML	SYRUP / ORAL		2013-03-28	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A091295-001	CYPROHEPTADINE HYDROCHLORIDE	2MG/5ML	SYRUP / ORAL		2013-03-28	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091295-001	CYPROHEPTADINE HYDROCHLORIDE	2MG/5ML	SYRUP / ORAL		2013-03-28	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091295-001	CYPROHEPTADINE HYDROCHLORIDE	2MG/5ML	SYRUP / ORAL		2013-03-28	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091295-001	CYPROHEPTADINE HYDROCHLORIDE	2MG/5ML	SYRUP / ORAL		2013-03-28	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091295-001	CYPROHEPTADINE HYDROCHLORIDE	2MG/5ML	SYRUP / ORAL		2013-03-28	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091295-001	CYPROHEPTADINE HYDROCHLORIDE	2MG/5ML	SYRUP / ORAL		2013-03-28	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091295-001	CYPROHEPTADINE HYDROCHLORIDE	2MG/5ML	SYRUP / ORAL		2013-03-28	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A091295-001	CYPROHEPTADINE HYDROCHLORIDE	2MG/5ML	SYRUP / ORAL		2013-03-28	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091295-001	CYPROHEPTADINE HYDROCHLORIDE	2MG/5ML	SYRUP / ORAL		2013-03-28	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091295-001	CYPROHEPTADINE HYDROCHLORIDE	2MG/5ML	SYRUP / ORAL		2013-03-28	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091295-001	CYPROHEPTADINE HYDROCHLORIDE	2MG/5ML	SYRUP / ORAL		2013-03-28	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A091295-001	CYPROHEPTADINE HYDROCHLORIDE	2MG/5ML	SYRUP / ORAL		2013-03-28	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A091295-001	CYPROHEPTADINE HYDROCHLORIDE	2MG/5ML	SYRUP / ORAL	AA	2013-03-28	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A091295-001	CYPROHEPTADINE HYDROCHLORIDE	2MG/5ML	SYRUP / ORAL	AA	2013-03-28	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A091295-001	CYPROHEPTADINE HYDROCHLORIDE	2MG/5ML	SYRUP / ORAL	AA	2013-03-28	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A091295-001	CYPROHEPTADINE HYDROCHLORIDE	2MG/5ML	SYRUP / ORAL	AA	2013-03-28	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A091295-001	CYPROHEPTADINE HYDROCHLORIDE	2MG/5ML	SYRUP / ORAL	AA	2013-03-28	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A091295-001	CYPROHEPTADINE HYDROCHLORIDE	2MG/5ML	SYRUP / ORAL	AA	2013-03-28	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A091295-001	CYPROHEPTADINE HYDROCHLORIDE	2MG/5ML	SYRUP / ORAL	AA	2013-03-28	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A091295-001	CYPROHEPTADINE HYDROCHLORIDE	2MG/5ML	SYRUP / ORAL	AA	2013-03-28	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A091295-001	CYPROHEPTADINE HYDROCHLORIDE	2MG/5ML	SYRUP / ORAL	AA	2013-03-28	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A091295-001	CYPROHEPTADINE HYDROCHLORIDE	2MG/5ML	SYRUP / ORAL	AA	2013-03-28	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A091295-001	CYPROHEPTADINE HYDROCHLORIDE	2MG/5ML	SYRUP / ORAL	AA	2013-03-28	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A091295-001	CYPROHEPTADINE HYDROCHLORIDE	2MG/5ML	SYRUP / ORAL	AA	2013-03-28	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A091295-001	CYPROHEPTADINE HYDROCHLORIDE	2MG/5ML	SYRUP / ORAL	AA	2013-03-28	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A091295-001	CYPROHEPTADINE HYDROCHLORIDE	2MG/5ML	SYRUP / ORAL		2013-03-28	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A091295-001	CYPROHEPTADINE HYDROCHLORIDE	2MG/5ML	SYRUP / ORAL	AA	2013-03-28	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A091295-001	CYPROHEPTADINE HYDROCHLORIDE	2MG/5ML	SYRUP / ORAL	AA	2013-03-28	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A091295-001	CYPROHEPTADINE HYDROCHLORIDE	2MG/5ML	SYRUP / ORAL	AA	2013-03-28	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A091295-001	CYPROHEPTADINE HYDROCHLORIDE	2MG/5ML	SYRUP / ORAL	AA	2013-03-28	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A091295-001	CYPROHEPTADINE HYDROCHLORIDE	2MG/5ML	SYRUP / ORAL	AA	2013-03-28	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A091295-001	CYPROHEPTADINE HYDROCHLORIDE	2MG/5ML	SYRUP / ORAL	AA	2013-03-28	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A091295-001	CYPROHEPTADINE HYDROCHLORIDE	2MG/5ML	SYRUP / ORAL	AA	2013-03-28	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A091295-001	CYPROHEPTADINE HYDROCHLORIDE	2MG/5ML	SYRUP / ORAL	AA	2013-03-28	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A091295-001	CYPROHEPTADINE HYDROCHLORIDE	2MG/5ML	SYRUP / ORAL	AA	2013-03-28	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A091295-001	CYPROHEPTADINE HYDROCHLORIDE	2MG/5ML	SYRUP / ORAL	AA	2013-03-28	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A091295-001	CYPROHEPTADINE HYDROCHLORIDE	2MG/5ML	SYRUP / ORAL	AA	2013-03-28	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A091295-001	CYPROHEPTADINE HYDROCHLORIDE	2MG/5ML	SYRUP / ORAL	AA	2013-03-28	`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	A091295-001	AA	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A091295-001	AA	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A091295-001	AA	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A091295-001	AA	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A091295-001	AA	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A091295-001	AA	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A091295-001	AA	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A091295-001	AA	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A091295-001	AA	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A091295-001	AA	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A091295-001	AA	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A091295-001	AA	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A091295-001	AA	1	`ea99ee380514…`
2024-02-18 07:12 UTC	2024-02	A091295-001	AA	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A091295-001	AA	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A091295-001	AA	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A091295-001	AA	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A091295-001	AA	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A091295-001	AA	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A091295-001	AA	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A091295-001	AA	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A091295-001	AA	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A091295-001	AA	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A091295-001	AA	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A091295-001	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 2 of 2 · 34 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
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
Cyproheptadine Hydrochloride	CYPROHEPTADINE HYDROCHLORIDE	Bryant Ranch Prepack	6a5b5a89-82c2-4991-b026-d160d8fa59a3	2024-05-23	Warnings, Adverse reactions	Name fallback brand name: Cyproheptadine Hydrochloride generic name: CYPROHEPTADINE HYDROCHLORIDE
CYPROHEPTADINE HYDROCHLORIDE	CYPROHEPTADINE HYDROCHLORIDE	Bryant Ranch Prepack	ab58d4df-69d4-43ac-ac6c-871fcc6c946d	2023-11-28	Warnings, Adverse reactions	Name fallback brand name: CYPROHEPTADINE HYDROCHLORIDE generic name: CYPROHEPTADINE HYDROCHLORIDE
CYPROHEPTADINE HYDROCHLORIDE	CYPROHEPTADINE HYDROCHLORIDE	A-S Medication Solutions	0e43e99b-2e0b-4f55-b93a-a6908634880d	2023-11-02	Warnings, Adverse reactions	Name fallback brand name: CYPROHEPTADINE HYDROCHLORIDE generic name: CYPROHEPTADINE HYDROCHLORIDE
CYPROHEPTADINE	CYPROHEPTADINE HYDROCHLORIDE	Chartwell RX, LLC	37fe7264-4d45-4d6c-ac13-40fcd1d82351	2023-10-05	Warnings, Adverse reactions	Name fallback generic name: CYPROHEPTADINE HYDROCHLORIDE
Cyproheptadine Hydrochloride	CYPROHEPTADINE HYDROCHLORIDE	A-S Medication Solutions	7e156e5e-e4cc-420b-8f1a-af123eaa9156	2023-09-18	Warnings, Adverse reactions	Name fallback brand name: Cyproheptadine Hydrochloride generic name: CYPROHEPTADINE HYDROCHLORIDE
CYPROHEPTADINE HYDROCHLORIDE	CYPROHEPTADINE HYDROCHLORIDE	Bryant Ranch Prepack	1bfb14ad-b522-4ad6-8c9f-2d99dd0dce64	2023-08-15	Warnings, Adverse reactions	Name fallback brand name: CYPROHEPTADINE HYDROCHLORIDE generic name: CYPROHEPTADINE HYDROCHLORIDE
Cyproheptadine Hydrochloride	CYPROHEPTADINE HYDROCHLORIDE	Chartwell RX, LLC	029ed3b6-175e-4a1a-81ed-350bff5f6167	2023-01-27	Warnings, Adverse reactions	Name fallback brand name: Cyproheptadine Hydrochloride generic name: CYPROHEPTADINE HYDROCHLORIDE
CYPROHEPTADINE HYDROCHLORIDE	CYPROHEPTADINE HYDROCHLORIDE	Zydus Pharmaceuticals USA Inc.	766f9b59-2c72-45ac-af09-5dd6c3e16b52	2022-10-04	Warnings, Adverse reactions	Name fallback brand name: CYPROHEPTADINE HYDROCHLORIDE generic name: CYPROHEPTADINE HYDROCHLORIDE
CYPROHEPTADINE HYDROCHLORIDE	CYPROHEPTADINE HYDROCHLORIDE	QUAGEN PHARMACEUTICALS LLC	98e71865-83dd-4e29-8308-c56e36731d96	2022-07-08	Warnings, Adverse reactions	Name fallback brand name: CYPROHEPTADINE HYDROCHLORIDE generic name: CYPROHEPTADINE HYDROCHLORIDE
Cyproheptadine Hydrochloride	CYPROHEPTADINE HYDROCHLORIDE	TRUPHARMA, LLC	9c0b47c0-ecd2-450f-9dcb-c262db92866e	2022-03-25	Warnings, Adverse reactions	Name fallback brand name: Cyproheptadine Hydrochloride generic name: CYPROHEPTADINE HYDROCHLORIDE
Cyproheptadine Hydrochloride	CYPROHEPTADINE HYDROCHLORIDE	Tris Pharma Inc	2b438746-14c2-44ef-a127-62b8d2efdc55	2022-03-15	Warnings, Adverse reactions	Name fallback brand name: Cyproheptadine Hydrochloride generic name: CYPROHEPTADINE HYDROCHLORIDE
Cyproheptadine Hydrochloride	CYPROHEPTADINE HYDROCHLORIDE	Patrin Pharma, Inc.	81d9523f-f945-4410-8b71-8b5fea48a3da	2022-02-24	Warnings, Adverse reactions	Name fallback brand name: Cyproheptadine Hydrochloride generic name: CYPROHEPTADINE HYDROCHLORIDE
Cyproheptadine Hydrochloride	CYPROHEPTADINE HYDROCHLORIDE	Rising Pharma Holdings, Inc.	c5e9e983-d0d2-4f87-beae-0d853ca43983	2022-02-08	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 · 2 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0121-0788	CYPROHEPTADINE	CYPROHEPTADINE	Pharmaceutical Associates, Inc.	ANDA	Current
0121-4788	CYPROHEPTADINE	CYPROHEPTADINE	Pharmaceutical Associates, Inc.	ANDA	Current