Application 211163

Type: ANDA
Sponsor: MACLEODS PHARMS LTD

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	TABLET, EXTENDED RELEASE;ORAL	1GM	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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
A211163-001	METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	1GM	TABLET, EXTENDED RELEASE / ORAL			2024-03-13

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.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A211163-001	METFORMIN HYDROCHLORIDE	1GM	TABLET, EXTENDED RELEASE / ORAL		2024-03-13	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A211163-001	METFORMIN HYDROCHLORIDE	1GM	TABLET, EXTENDED RELEASE / ORAL		2024-03-13	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A211163-001	METFORMIN HYDROCHLORIDE	1GM	TABLET, EXTENDED RELEASE / ORAL		2024-03-13	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211163-001	METFORMIN HYDROCHLORIDE	1GM	TABLET, EXTENDED RELEASE / ORAL		2024-03-13	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A211163-001	METFORMIN HYDROCHLORIDE	1GM	TABLET, EXTENDED RELEASE / ORAL		2024-03-13	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211163-001	METFORMIN HYDROCHLORIDE	1GM	TABLET, EXTENDED RELEASE / ORAL		2024-03-13	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211163-001	METFORMIN HYDROCHLORIDE	1GM	TABLET, EXTENDED RELEASE / ORAL		2024-03-13	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211163-001	METFORMIN HYDROCHLORIDE	1GM	TABLET, EXTENDED RELEASE / ORAL		2024-03-13	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211163-001	METFORMIN HYDROCHLORIDE	1GM	TABLET, EXTENDED RELEASE / ORAL	AB3	2024-03-13	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211163-001	METFORMIN HYDROCHLORIDE	1GM	TABLET, EXTENDED RELEASE / ORAL	AB3	2024-03-13	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211163-001	METFORMIN HYDROCHLORIDE	1GM	TABLET, EXTENDED RELEASE / ORAL	AB3	2024-03-13	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A211163-001	METFORMIN HYDROCHLORIDE	1GM	TABLET, EXTENDED RELEASE / ORAL	AB3	2024-03-13	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A211163-001	METFORMIN HYDROCHLORIDE	1GM	TABLET, EXTENDED RELEASE / ORAL	AB3	2024-03-13	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A211163-001	METFORMIN HYDROCHLORIDE	1GM	TABLET, EXTENDED RELEASE / ORAL	AB3	2024-03-13	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A211163-001	METFORMIN HYDROCHLORIDE	1GM	TABLET, EXTENDED RELEASE / ORAL	AB3	2024-03-13	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A211163-001	METFORMIN HYDROCHLORIDE	1GM	TABLET, EXTENDED RELEASE / ORAL	AB3	2024-03-13	`8072bd15b7f6…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A211163-001	METFORMIN HYDROCHLORIDE	1GM	TABLET, EXTENDED RELEASE / ORAL		2024-03-13	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211163-001	AB3	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211163-001	AB3	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211163-001	AB3	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A211163-001	AB3	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A211163-001	AB3	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A211163-001	AB3	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A211163-001	AB3	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A211163-001	AB3	1	`8072bd15b7f6…`

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 14 · 261 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Metformin Hydrochloride	METFORMIN HYDROCHLORIDE	PD-Rx Pharmaceuticals, Inc.	1d0b74de-ef4c-4dd2-8019-2ddb409c60b4	2026-08-03	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Metformin Hydrochloride generic name: METFORMIN HYDROCHLORIDE
Metformin Hydrochloride	METFORMIN HYDROCHLORIDE	REMEDYREPACK INC.	59a4ccda-5487-4ac4-9373-0c0fc8b7c88b	2026-08-03	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Metformin Hydrochloride generic name: METFORMIN HYDROCHLORIDE
METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	PD-Rx Pharmaceuticals, Inc.	f55a245b-a786-4a4a-b11c-c61d48294b01	2026-07-31	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: METFORMIN HYDROCHLORIDE generic name: METFORMIN HYDROCHLORIDE
Metformin Hydrochloride	METFORMIN HYDROCHLORIDE	PD-Rx Pharmaceuticals, Inc.	41408f64-d366-403e-9595-464ab25c6f97	2026-07-30	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Metformin Hydrochloride generic name: METFORMIN HYDROCHLORIDE
Metformin Hydrochloride	METFORMIN HYDROCHLORIDE	PD-Rx Pharmaceuticals, Inc.	68d0b1a6-c99e-42cf-afdf-b71ee73c4424	2026-07-30	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Metformin Hydrochloride generic name: METFORMIN HYDROCHLORIDE
METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	PD-Rx Pharmaceuticals, Inc.	9171d369-d35a-40e4-a9ad-26484e66fc5e	2026-07-29	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: METFORMIN HYDROCHLORIDE generic name: METFORMIN HYDROCHLORIDE
Metformin Hydrochloride	METFORMIN HYDROCHLORIDE	REMEDYREPACK INC.	30658e19-8e6e-49aa-a007-e414224797c5	2026-07-29	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Metformin Hydrochloride generic name: METFORMIN HYDROCHLORIDE
Metformin Hydrochloride	METFORMIN HYDROCHLORIDE	REMEDYREPACK INC.	1503bbe4-0ac5-479b-9900-d38e49236bf0	2026-07-28	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Metformin Hydrochloride generic name: METFORMIN HYDROCHLORIDE
Metformin Hydrochloride	METFORMIN HYDROCHLORIDE	Cardinal Health 107, LLC	46cb7e3f-c739-433d-9dbe-427c2d95bef1	2026-07-24	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Metformin Hydrochloride generic name: METFORMIN HYDROCHLORIDE
Metformin Hydrochloride	METFORMIN HYDROCHLORIDE	Chartwell RX, LLC	4d3dbf6f-1c8a-4daa-8343-8cd8f64a65cd	2026-07-20	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Metformin Hydrochloride generic name: METFORMIN HYDROCHLORIDE
Metformin Hydrochloride	METFORMIN HYDROCHLORIDE	REMEDYREPACK INC.	13235d8e-ac3a-45b4-9c5d-9a9012951dfe	2026-07-16	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Metformin Hydrochloride generic name: METFORMIN HYDROCHLORIDE
METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	Zydus Pharmaceuticals USA Inc.	c82a10fa-1e8e-46b6-890a-737de3f34ee1	2026-07-15	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: METFORMIN HYDROCHLORIDE generic name: METFORMIN HYDROCHLORIDE
Metformin Hydrochloride	METFORMIN HYDROCHLORIDE	REMEDYREPACK INC.	5aa1c86c-f2c8-49b1-8f81-47b11386c5d3	2026-07-15	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Metformin Hydrochloride generic name: METFORMIN HYDROCHLORIDE
Metformin Hydrochloride	METFORMIN HYDROCHLORIDE	Aurobindo Pharma Limited	4ac6d01a-af26-44e7-ae2e-3618de0080aa	2026-07-15	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Metformin Hydrochloride generic name: METFORMIN HYDROCHLORIDE
Metformin Hydrochloride	METFORMIN HYDROCHLORIDE	Advanced Rx of Tennessee, LLC	5647230e-5bc6-1802-e063-6394a90a2724	2026-07-10	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Metformin Hydrochloride generic name: METFORMIN HYDROCHLORIDE
Metformin Hydrochloride	METFORMIN HYDROCHLORIDE	Aurobindo Pharma Limited	fc466c46-abaa-4675-aef2-4b1a1adfd912	2026-07-08	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Metformin Hydrochloride generic name: METFORMIN HYDROCHLORIDE
METFORMIN HYDROCHLORIDE EXTENDED RELEASE	METFORMIN HYDROCHLORIDE	PD-Rx Pharmaceuticals, Inc.	14f3091c-f243-4364-b433-727c7d4ef8d5	2026-07-07	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: METFORMIN HYDROCHLORIDE
Metformin hydrochloride	METFORMIN HYDROCHLORIDE	PD-Rx Pharmaceuticals, Inc.	17050df5-9e95-4e1b-ac75-34add289b139	2026-07-07	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Metformin hydrochloride generic name: METFORMIN HYDROCHLORIDE
Metformin Hydrochloride	METFORMIN HYDROCHLORIDE	Amneal Pharmaceuticals LLC	dc65065b-cba0-46d7-8fb5-3368f3210b4d	2026-07-01	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Metformin Hydrochloride generic name: METFORMIN HYDROCHLORIDE
Metformin Hydrochloride	METFORMIN HYDROCHLORIDE	Unichem Pharmaceuticals (USA), Inc.	9eebed09-2562-4d21-b3b3-c06562fe3f99	2026-07-01	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.