Application 213394

Type: ANDA
Sponsor: AMTA

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	TABLET, EXTENDED RELEASE;ORAL	500MG	No	No
002	METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	TABLET, EXTENDED RELEASE;ORAL	1GM	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
A213394-001	METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE / ORAL			2021-08-03
A213394-002	METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	1GM	TABLET, EXTENDED RELEASE / ORAL			2021-08-03

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	Product TE source text	Approval date	Source SHA-256
2022-03-09 01:35 UTC	2022-03	A213394-001	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE / ORAL		2021-08-03	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A213394-002	METFORMIN HYDROCHLORIDE	1GM	TABLET, EXTENDED RELEASE / ORAL		2021-08-03	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A213394-001	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB2	2021-08-03	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A213394-002	METFORMIN HYDROCHLORIDE	1GM	TABLET, EXTENDED RELEASE / ORAL	AB2	2021-08-03	`782e0a99824c…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A213394-001	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE / ORAL		2021-08-03	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A213394-002	METFORMIN HYDROCHLORIDE	1GM	TABLET, EXTENDED RELEASE / ORAL		2021-08-03	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A213394-001	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE / ORAL		2021-08-03	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A213394-002	METFORMIN HYDROCHLORIDE	1GM	TABLET, EXTENDED RELEASE / ORAL		2021-08-03	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A213394-001	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE / ORAL		2021-08-03	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A213394-002	METFORMIN HYDROCHLORIDE	1GM	TABLET, EXTENDED RELEASE / ORAL		2021-08-03	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A213394-001	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE / ORAL		2021-08-03	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A213394-002	METFORMIN HYDROCHLORIDE	1GM	TABLET, EXTENDED RELEASE / ORAL		2021-08-03	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A213394-001	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE / ORAL		2021-08-03	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A213394-002	METFORMIN HYDROCHLORIDE	1GM	TABLET, EXTENDED RELEASE / ORAL		2021-08-03	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A213394-001	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE / ORAL		2021-08-03	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A213394-002	METFORMIN HYDROCHLORIDE	1GM	TABLET, EXTENDED RELEASE / ORAL		2021-08-03	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A213394-001	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE / ORAL		2021-08-03	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A213394-002	METFORMIN HYDROCHLORIDE	1GM	TABLET, EXTENDED RELEASE / ORAL		2021-08-03	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A213394-001	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE / ORAL		2021-08-03	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	A213394-002	METFORMIN HYDROCHLORIDE	1GM	TABLET, EXTENDED RELEASE / ORAL		2021-08-03	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A213394-001	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE / ORAL		2021-08-03	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	A213394-002	METFORMIN HYDROCHLORIDE	1GM	TABLET, EXTENDED RELEASE / ORAL		2021-08-03	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A213394-001	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE / ORAL		2021-08-03	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A213394-002	METFORMIN HYDROCHLORIDE	1GM	TABLET, EXTENDED RELEASE / ORAL		2021-08-03	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A213394-001	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE / ORAL		2021-08-03	`f41ea6bd6efb…`
2022-10-28 04:53 UTC	2022-10	A213394-002	METFORMIN HYDROCHLORIDE	1GM	TABLET, EXTENDED RELEASE / ORAL		2021-08-03	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A213394-001	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE / ORAL		2021-08-03	`e64feba35796…`
2022-09-29 23:25 UTC	2022-09	A213394-002	METFORMIN HYDROCHLORIDE	1GM	TABLET, EXTENDED RELEASE / ORAL		2021-08-03	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A213394-001	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE / ORAL		2021-08-03	`cb3db0bc1861…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A213394-002	METFORMIN HYDROCHLORIDE	1GM	TABLET, EXTENDED RELEASE / ORAL		2021-08-03	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A213394-001	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE / ORAL		2021-08-03	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A213394-002	METFORMIN HYDROCHLORIDE	1GM	TABLET, EXTENDED RELEASE / ORAL		2021-08-03	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2021-12-28 21:50 UTC	2021-12	A213394-001	AB2	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A213394-002	AB2	1	`782e0a99824c…`

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 13 · 251 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Metformin Hydrochloride	METFORMIN HYDROCHLORIDE	REMEDYREPACK INC.	d5228e81-9c86-4781-b984-20feaa2ae779	2026-09-09	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Metformin Hydrochloride generic name: METFORMIN HYDROCHLORIDE
Metformin Hydrochloride	METFORMIN HYDROCHLORIDE	Camber Pharmaceuticals, Inc.	7cc02a26-5c22-445b-ad8f-3e7570c143d3	2026-09-08	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Metformin Hydrochloride generic name: METFORMIN HYDROCHLORIDE
METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	Granules India Ltd	73197cb5-3e23-4ac0-b189-f9bc848bce66	2026-09-03	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: METFORMIN HYDROCHLORIDE generic name: METFORMIN HYDROCHLORIDE
METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	A-S Medication Solutions	b6d7edc9-93d6-4480-906d-55c18d053600	2026-09-02	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: METFORMIN HYDROCHLORIDE generic name: METFORMIN HYDROCHLORIDE
METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	A-S Medication Solutions	64f5b140-7ad8-4c07-bbfc-ae4618afa850	2026-09-01	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: METFORMIN HYDROCHLORIDE generic name: METFORMIN HYDROCHLORIDE
Metformin Hydrochloride	METFORMIN HYDROCHLORIDE	REMEDYREPACK INC.	bfd6ec0f-8264-4877-aa6d-f347f53bc426	2026-09-01	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Metformin Hydrochloride generic name: METFORMIN HYDROCHLORIDE
Metformin Hydrochloride	METFORMIN HYDROCHLORIDE	REMEDYREPACK INC.	c568d49f-c040-4f1e-ad36-77b05ab659c3	2026-08-28	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Metformin Hydrochloride generic name: METFORMIN HYDROCHLORIDE
Metformin Hydrochloride	METFORMIN HYDROCHLORIDE	Preferred Pharmaceuticals Inc.	ba0379cb-824e-4798-9ff9-99bcd1bea5cb	2026-08-27	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Metformin Hydrochloride generic name: METFORMIN HYDROCHLORIDE
Metformin Hydrochloride	METFORMIN HYDROCHLORIDE	Bryant Ranch Prepack	fb296500-55cb-45ce-be0c-59aa2e3d4624	2026-08-26	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Metformin Hydrochloride generic name: METFORMIN HYDROCHLORIDE
METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	ScieGen Pharmaceuticals Inc	4e4c4ba9-65c6-4273-8f6b-2423ab521dad	2026-08-21	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: METFORMIN HYDROCHLORIDE generic name: METFORMIN HYDROCHLORIDE
Metformin Hydrochloride	METFORMIN HYDROCHLORIDE	REMEDYREPACK INC.	073cf6d9-7142-4d8b-898e-174c62a1f76f	2026-08-21	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Metformin Hydrochloride generic name: METFORMIN HYDROCHLORIDE
METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	QPharma,Inc.	5866ca12-a28f-cbe7-e063-6294a90acc69	2026-08-20	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: METFORMIN HYDROCHLORIDE generic name: METFORMIN HYDROCHLORIDE
METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	Quallent Pharmaceuticals Health LLC	25be863d-490c-47f6-9ad3-c828dc43fbf0	2026-08-12	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: METFORMIN HYDROCHLORIDE generic name: METFORMIN HYDROCHLORIDE
METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	Redpharm Drug	58bec665-b648-6baf-e063-6394a90a1cbb	2026-08-11	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: METFORMIN HYDROCHLORIDE generic name: METFORMIN HYDROCHLORIDE
Metformin Hydrochloride	METFORMIN HYDROCHLORIDE	REMEDYREPACK INC.	e22a8545-86a6-439e-a758-29c4d6ed8bfe	2026-08-11	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Metformin Hydrochloride generic name: METFORMIN HYDROCHLORIDE
Metformin Hydrochloride	METFORMIN HYDROCHLORIDE	Bryant Ranch Prepack	c1bfc7b5-c7e0-4353-b772-05d463c12886	2026-08-04	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Metformin Hydrochloride generic name: METFORMIN HYDROCHLORIDE
Metformin Hydrochloride	METFORMIN HYDROCHLORIDE	REMEDYREPACK INC.	1e8136e0-cc98-41e4-ad4b-a8fc27fb4daa	2026-08-04	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Metformin Hydrochloride generic name: METFORMIN HYDROCHLORIDE
METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	PD-Rx Pharmaceuticals, Inc.	4d087f00-580b-4b9d-80d9-f97930153e72	2026-08-04	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: METFORMIN HYDROCHLORIDE generic name: METFORMIN HYDROCHLORIDE
Metformin Hydrochloride	METFORMIN HYDROCHLORIDE	REMEDYREPACK INC.	5d8d654a-9bb4-4c87-ab43-c21c4e874708	2026-08-04	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Metformin Hydrochloride generic name: METFORMIN HYDROCHLORIDE
Metformin Hydrochloride	METFORMIN HYDROCHLORIDE	NuCare Pharmaceuticals, Inc.	583f2a2e-a9d7-f266-e063-6294a90ad0ab	2026-08-04	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Metformin Hydrochloride generic name: METFORMIN HYDROCHLORIDE

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.