Application 216030

Type: ANDA
Sponsor: ASCENT PHARMS INC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	FAMOTIDINE	FAMOTIDINE	TABLET;ORAL	10MG	No	No
002	FAMOTIDINE	FAMOTIDINE	TABLET;ORAL	20MG	No	No

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

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A216030-001	FAMOTIDINE	FAMOTIDINE	10MG	TABLET / ORAL			2021-11-03
A216030-002	FAMOTIDINE	FAMOTIDINE	20MG	TABLET / ORAL			2021-11-03

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 2 of 2 · 72 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2022-03-09 01:35 UTC	2022-03	A216030-001	FAMOTIDINE	10MG	TABLET / ORAL	2021-11-03	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A216030-002	FAMOTIDINE	20MG	TABLET / ORAL	2021-11-03	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A216030-001	FAMOTIDINE	10MG	TABLET / ORAL	2021-11-03	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A216030-002	FAMOTIDINE	20MG	TABLET / ORAL	2021-11-03	`782e0a99824c…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A216030-001	FAMOTIDINE	10MG	TABLET / ORAL	2021-11-03	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A216030-002	FAMOTIDINE	20MG	TABLET / ORAL	2021-11-03	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A216030-001	FAMOTIDINE	10MG	TABLET / ORAL	2021-11-03	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A216030-002	FAMOTIDINE	20MG	TABLET / ORAL	2021-11-03	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A216030-001	FAMOTIDINE	10MG	TABLET / ORAL	2021-11-03	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A216030-002	FAMOTIDINE	20MG	TABLET / ORAL	2021-11-03	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A216030-001	FAMOTIDINE	10MG	TABLET / ORAL	2021-11-03	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A216030-002	FAMOTIDINE	20MG	TABLET / ORAL	2021-11-03	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A216030-001	FAMOTIDINE	10MG	TABLET / ORAL	2021-11-03	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A216030-002	FAMOTIDINE	20MG	TABLET / ORAL	2021-11-03	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A216030-001	FAMOTIDINE	10MG	TABLET / ORAL	2021-11-03	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A216030-002	FAMOTIDINE	20MG	TABLET / ORAL	2021-11-03	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A216030-001	FAMOTIDINE	10MG	TABLET / ORAL	2021-11-03	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A216030-002	FAMOTIDINE	20MG	TABLET / ORAL	2021-11-03	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A216030-001	FAMOTIDINE	10MG	TABLET / ORAL	2021-11-03	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	A216030-002	FAMOTIDINE	20MG	TABLET / ORAL	2021-11-03	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A216030-001	FAMOTIDINE	10MG	TABLET / ORAL	2021-11-03	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	A216030-002	FAMOTIDINE	20MG	TABLET / ORAL	2021-11-03	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A216030-001	FAMOTIDINE	10MG	TABLET / ORAL	2021-11-03	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A216030-002	FAMOTIDINE	20MG	TABLET / ORAL	2021-11-03	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A216030-001	FAMOTIDINE	10MG	TABLET / ORAL	2021-11-03	`f41ea6bd6efb…`
2022-10-28 04:53 UTC	2022-10	A216030-002	FAMOTIDINE	20MG	TABLET / ORAL	2021-11-03	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A216030-001	FAMOTIDINE	10MG	TABLET / ORAL	2021-11-03	`e64feba35796…`
2022-09-29 23:25 UTC	2022-09	A216030-002	FAMOTIDINE	20MG	TABLET / ORAL	2021-11-03	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A216030-001	FAMOTIDINE	10MG	TABLET / ORAL	2021-11-03	`cb3db0bc1861…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A216030-002	FAMOTIDINE	20MG	TABLET / ORAL	2021-11-03	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A216030-001	FAMOTIDINE	10MG	TABLET / ORAL	2021-11-03	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A216030-002	FAMOTIDINE	20MG	TABLET / ORAL	2021-11-03	`a50c72e98297…`

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
FAMOTIDINE	FAMOTIDINE	Ascent Pharmaceuticals, Inc.	b481dd30-7d64-43ec-85d4-2289db62cad7	2022-02-14	Warnings	Exact identifier application applno (ANDA): 216030 application number: ANDA216030 ndc (product): 43602-602 ndc (product): 43602-511

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 · 2 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
43602-511	FAMOTIDINE	Famotidine	Ascent Pharmaceuticals, Inc.	ANDA	Current
43602-602	FAMOTIDINE	Famotidine	Ascent Pharmaceuticals, Inc.	ANDA	Current