Application 207555

Type: ANDA
Sponsor: ELYSIUM

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
A207555-001	CYPROHEPTADINE HYDROCHLORIDE	CYPROHEPTADINE HYDROCHLORIDE	4MG	TABLET / ORAL	AA		2017-01-31

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A207555-001	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	A207555-001	CYPROHEPTADINE HYDROCHLORIDE	4MG	TABLET / ORAL	AA	2017-01-31	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207555-001	CYPROHEPTADINE HYDROCHLORIDE	4MG	TABLET / ORAL	AA	2017-01-31	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A207555-001	CYPROHEPTADINE HYDROCHLORIDE	4MG	TABLET / ORAL	AA	2017-01-31	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207555-001	CYPROHEPTADINE HYDROCHLORIDE	4MG	TABLET / ORAL	AA	2017-01-31	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207555-001	CYPROHEPTADINE HYDROCHLORIDE	4MG	TABLET / ORAL	AA	2017-01-31	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207555-001	CYPROHEPTADINE HYDROCHLORIDE	4MG	TABLET / ORAL	AA	2017-01-31	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207555-001	CYPROHEPTADINE HYDROCHLORIDE	4MG	TABLET / ORAL	AA	2017-01-31	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207555-001	CYPROHEPTADINE HYDROCHLORIDE	4MG	TABLET / ORAL	AA	2017-01-31	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207555-001	CYPROHEPTADINE HYDROCHLORIDE	4MG	TABLET / ORAL	AA	2017-01-31	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A207555-001	CYPROHEPTADINE HYDROCHLORIDE	4MG	TABLET / ORAL	AA	2017-01-31	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207555-001	CYPROHEPTADINE HYDROCHLORIDE	4MG	TABLET / ORAL	AA	2017-01-31	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207555-001	CYPROHEPTADINE HYDROCHLORIDE	4MG	TABLET / ORAL	AA	2017-01-31	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A207555-001	CYPROHEPTADINE HYDROCHLORIDE	4MG	TABLET / ORAL	AA	2017-01-31	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A207555-001	CYPROHEPTADINE HYDROCHLORIDE	4MG	TABLET / ORAL	AA	2017-01-31	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A207555-001	CYPROHEPTADINE HYDROCHLORIDE	4MG	TABLET / ORAL	AA	2017-01-31	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A207555-001	CYPROHEPTADINE HYDROCHLORIDE	4MG	TABLET / ORAL	AA	2017-01-31	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A207555-001	CYPROHEPTADINE HYDROCHLORIDE	4MG	TABLET / ORAL	AA	2017-01-31	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A207555-001	CYPROHEPTADINE HYDROCHLORIDE	4MG	TABLET / ORAL	AA	2017-01-31	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A207555-001	CYPROHEPTADINE HYDROCHLORIDE	4MG	TABLET / ORAL	AA	2017-01-31	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A207555-001	CYPROHEPTADINE HYDROCHLORIDE	4MG	TABLET / ORAL	AA	2017-01-31	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A207555-001	CYPROHEPTADINE HYDROCHLORIDE	4MG	TABLET / ORAL	AA	2017-01-31	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A207555-001	CYPROHEPTADINE HYDROCHLORIDE	4MG	TABLET / ORAL	AA	2017-01-31	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A207555-001	CYPROHEPTADINE HYDROCHLORIDE	4MG	TABLET / ORAL	AA	2017-01-31	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A207555-001	CYPROHEPTADINE HYDROCHLORIDE	4MG	TABLET / ORAL	AA	2017-01-31	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A207555-001	CYPROHEPTADINE HYDROCHLORIDE	4MG	TABLET / ORAL	AA	2017-01-31	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A207555-001	CYPROHEPTADINE HYDROCHLORIDE	4MG	TABLET / ORAL	AA	2017-01-31	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A207555-001	CYPROHEPTADINE HYDROCHLORIDE	4MG	TABLET / ORAL	AA	2017-01-31	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A207555-001	CYPROHEPTADINE HYDROCHLORIDE	4MG	TABLET / ORAL	AA	2017-01-31	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A207555-001	CYPROHEPTADINE HYDROCHLORIDE	4MG	TABLET / ORAL	AA	2017-01-31	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A207555-001	CYPROHEPTADINE HYDROCHLORIDE	4MG	TABLET / ORAL	AA	2017-01-31	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A207555-001	CYPROHEPTADINE HYDROCHLORIDE	4MG	TABLET / ORAL	AA	2017-01-31	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A207555-001	CYPROHEPTADINE HYDROCHLORIDE	4MG	TABLET / ORAL	AA	2017-01-31	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A207555-001	CYPROHEPTADINE HYDROCHLORIDE	4MG	TABLET / ORAL	AA	2017-01-31	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A207555-001	CYPROHEPTADINE HYDROCHLORIDE	4MG	TABLET / ORAL	AA	2017-01-31	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A207555-001	CYPROHEPTADINE HYDROCHLORIDE	4MG	TABLET / ORAL	AA	2017-01-31	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A207555-001	CYPROHEPTADINE HYDROCHLORIDE	4MG	TABLET / ORAL	AA	2017-01-31	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A207555-001	CYPROHEPTADINE HYDROCHLORIDE	4MG	TABLET / ORAL	AA	2017-01-31	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A207555-001	CYPROHEPTADINE HYDROCHLORIDE	4MG	TABLET / ORAL	AA	2017-01-31	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A207555-001	CYPROHEPTADINE HYDROCHLORIDE	4MG	TABLET / ORAL	AA	2017-01-31	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A207555-001	CYPROHEPTADINE HYDROCHLORIDE	4MG	TABLET / ORAL	AA	2017-01-31	`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	A207555-001	AA	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207555-001	AA	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A207555-001	AA	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207555-001	AA	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207555-001	AA	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207555-001	AA	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207555-001	AA	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207555-001	AA	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207555-001	AA	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A207555-001	AA	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207555-001	AA	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207555-001	AA	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A207555-001	AA	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A207555-001	AA	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A207555-001	AA	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A207555-001	AA	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A207555-001	AA	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A207555-001	AA	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A207555-001	AA	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A207555-001	AA	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A207555-001	AA	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A207555-001	AA	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A207555-001	AA	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A207555-001	AA	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A207555-001	AA	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A207555-001	AA	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A207555-001	AA	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A207555-001	AA	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A207555-001	AA	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A207555-001	AA	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A207555-001	AA	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A207555-001	AA	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A207555-001	AA	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A207555-001	AA	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A207555-001	AA	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A207555-001	AA	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A207555-001	AA	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A207555-001	AA	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A207555-001	AA	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A207555-001	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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Cyproheptadine Hydrochloride	CYPROHEPTADINE HYDROCHLORIDE	Rising Pharma Holdings, Inc.	c5e9e983-d0d2-4f87-beae-0d853ca43983	2022-02-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207555 application number: ANDA207555 ndc (product): 16571-805

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 15 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
10135-638	Cyproheptadine Hydrochloride	Cyproheptadine Hydrochloride	Marlex Pharmaceuticals Inc	ANDA	Current
10135-638	Cyproheptadine Hydrochloride	Cyproheptadine Hydrochloride	Marlex Pharmaceuticals Inc	ANDA	Current
10135-638	Cyproheptadine Hydrochloride	Cyproheptadine Hydrochloride	Marlex Pharmaceuticals Inc	ANDA	Current
13811-694	Cyproheptadine Hydrochloride	Cyproheptadine Hydrochloride	Trigen Laboratories	ANDA	Current
16571-805	Cyproheptadine Hydrochloride	Cyproheptadine Hydrochloride	Rising Pharma Holdings, Inc.	ANDA	Current
24689-816	Cyproheptadine Hydrochloride	Cyproheptadine Hydrochloride	Apnar Pharma	ANDA	Current
24689-816	Cyproheptadine Hydrochloride	Cyproheptadine Hydrochloride	Apnar Pharma	ANDA	Current
24689-816	Cyproheptadine Hydrochloride	Cyproheptadine Hydrochloride	Apnar Pharma	ANDA	Current
50090-4724	Cyproheptadine Hydrochloride	Cyproheptadine Hydrochloride	A-S Medication Solutions	ANDA	Current
50268-189	Cyproheptadine Hydrochloride	Cyproheptadine Hydrochloride	AvPAK	ANDA	Current
50268-189	Cyproheptadine Hydrochloride	Cyproheptadine Hydrochloride	AvPAK	ANDA	Current
69367-246	Cyproheptadine Hydrochloride	Cyproheptadine Hydrochloride	Westminster Pharmaceuticals, LLC	ANDA	Current
71205-989	Cyproheptadine Hydrochloride	Cyproheptadine Hydrochloride	Proficient Rx LP	ANDA	Current
71205-989	Cyproheptadine Hydrochloride	Cyproheptadine Hydrochloride	Proficient Rx LP	ANDA	Current
71205-989	Cyproheptadine Hydrochloride	Cyproheptadine Hydrochloride	Proficient Rx LP	ANDA	Current