Application 079226

Type: ANDA
Sponsor: TORRENT 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	750MG	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
A079226-001	METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	750MG	TABLET, EXTENDED RELEASE / ORAL			2010-02-18

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 · 43 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A079226-001	METFORMIN HYDROCHLORIDE	750MG	TABLET, EXTENDED RELEASE / ORAL	2010-02-18	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A079226-001	METFORMIN HYDROCHLORIDE	750MG	TABLET, EXTENDED RELEASE / ORAL	2010-02-18	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A079226-001	METFORMIN HYDROCHLORIDE	750MG	TABLET, EXTENDED RELEASE / ORAL	2010-02-18	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A079226-001	METFORMIN HYDROCHLORIDE	750MG	TABLET, EXTENDED RELEASE / ORAL	2010-02-18	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A079226-001	METFORMIN HYDROCHLORIDE	750MG	TABLET, EXTENDED RELEASE / ORAL	2010-02-18	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A079226-001	METFORMIN HYDROCHLORIDE	750MG	TABLET, EXTENDED RELEASE / ORAL	2010-02-18	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A079226-001	METFORMIN HYDROCHLORIDE	750MG	TABLET, EXTENDED RELEASE / ORAL	2010-02-18	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A079226-001	METFORMIN HYDROCHLORIDE	750MG	TABLET, EXTENDED RELEASE / ORAL	2010-02-18	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A079226-001	METFORMIN HYDROCHLORIDE	750MG	TABLET, EXTENDED RELEASE / ORAL	2010-02-18	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A079226-001	METFORMIN HYDROCHLORIDE	750MG	TABLET, EXTENDED RELEASE / ORAL	2010-02-18	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A079226-001	METFORMIN HYDROCHLORIDE	750MG	TABLET, EXTENDED RELEASE / ORAL	2010-02-18	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A079226-001	METFORMIN HYDROCHLORIDE	750MG	TABLET, EXTENDED RELEASE / ORAL	2010-02-18	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A079226-001	METFORMIN HYDROCHLORIDE	750MG	TABLET, EXTENDED RELEASE / ORAL	2010-02-18	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A079226-001	METFORMIN HYDROCHLORIDE	750MG	TABLET, EXTENDED RELEASE / ORAL	2010-02-18	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A079226-001	METFORMIN HYDROCHLORIDE	750MG	TABLET, EXTENDED RELEASE / ORAL	2010-02-18	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A079226-001	METFORMIN HYDROCHLORIDE	750MG	TABLET, EXTENDED RELEASE / ORAL	2010-02-18	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A079226-001	METFORMIN HYDROCHLORIDE	750MG	TABLET, EXTENDED RELEASE / ORAL	2010-02-18	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A079226-001	METFORMIN HYDROCHLORIDE	750MG	TABLET, EXTENDED RELEASE / ORAL	2010-02-18	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A079226-001	METFORMIN HYDROCHLORIDE	750MG	TABLET, EXTENDED RELEASE / ORAL	2010-02-18	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A079226-001	METFORMIN HYDROCHLORIDE	750MG	TABLET, EXTENDED RELEASE / ORAL	2010-02-18	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A079226-001	METFORMIN HYDROCHLORIDE	750MG	TABLET, EXTENDED RELEASE / ORAL	2010-02-18	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A079226-001	METFORMIN HYDROCHLORIDE	750MG	TABLET, EXTENDED RELEASE / ORAL	2010-02-18	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A079226-001	METFORMIN HYDROCHLORIDE	750MG	TABLET, EXTENDED RELEASE / ORAL	2010-02-18	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A079226-001	METFORMIN HYDROCHLORIDE	750MG	TABLET, EXTENDED RELEASE / ORAL	2010-02-18	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A079226-001	METFORMIN HYDROCHLORIDE	750MG	TABLET, EXTENDED RELEASE / ORAL	2010-02-18	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A079226-001	METFORMIN HYDROCHLORIDE	750MG	TABLET, EXTENDED RELEASE / ORAL	2010-02-18	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A079226-001	METFORMIN HYDROCHLORIDE	750MG	TABLET, EXTENDED RELEASE / ORAL	2010-02-18	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A079226-001	METFORMIN HYDROCHLORIDE	750MG	TABLET, EXTENDED RELEASE / ORAL	2010-02-18	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A079226-001	METFORMIN HYDROCHLORIDE	750MG	TABLET, EXTENDED RELEASE / ORAL	2010-02-18	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A079226-001	METFORMIN HYDROCHLORIDE	750MG	TABLET, EXTENDED RELEASE / ORAL	2010-02-18	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A079226-001	METFORMIN HYDROCHLORIDE	750MG	TABLET, EXTENDED RELEASE / ORAL	2010-02-18	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A079226-001	METFORMIN HYDROCHLORIDE	750MG	TABLET, EXTENDED RELEASE / ORAL	2010-02-18	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A079226-001	METFORMIN HYDROCHLORIDE	750MG	TABLET, EXTENDED RELEASE / ORAL	2010-02-18	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A079226-001	METFORMIN HYDROCHLORIDE	750MG	TABLET, EXTENDED RELEASE / ORAL	2010-02-18	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A079226-001	METFORMIN HYDROCHLORIDE	750MG	TABLET, EXTENDED RELEASE / ORAL	2010-02-18	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A079226-001	METFORMIN HYDROCHLORIDE	750MG	TABLET, EXTENDED RELEASE / ORAL	2010-02-18	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A079226-001	METFORMIN HYDROCHLORIDE	750MG	TABLET, EXTENDED RELEASE / ORAL	2010-02-18	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A079226-001	METFORMIN HYDROCHLORIDE	750MG	TABLET, EXTENDED RELEASE / ORAL	2010-02-18	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A079226-001	METFORMIN HYDROCHLORIDE	750MG	TABLET, EXTENDED RELEASE / ORAL	2010-02-18	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A079226-001	METFORMIN HYDROCHLORIDE	750MG	TABLET, EXTENDED RELEASE / ORAL	2010-02-18	`f41ea6bd6efb…`

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 12 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	A-S Medication Solutions	a4679179-af2d-4c84-a1c8-ab0870a4585d	2023-10-18	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Metformin Hydrochloride generic name: METFORMIN HYDROCHLORIDE
METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	VGYAAN Pharmaceuticals LLC	129ff158-097f-401a-8924-d9258465c1f3	2023-09-22	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: METFORMIN HYDROCHLORIDE generic name: METFORMIN HYDROCHLORIDE
Metformin Hydrochloride	METFORMIN HYDROCHLORIDE	A-S Medication Solutions	d60139c2-fd35-4ab4-af7e-7410481edc2e	2023-09-18	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Metformin Hydrochloride generic name: METFORMIN HYDROCHLORIDE
Metformin Hydrochloride	METFORMIN HYDROCHLORIDE	Proficient Rx LP	1b9b6db9-1bac-4252-a03c-18dc0271f05f	2023-06-01	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Metformin Hydrochloride generic name: METFORMIN HYDROCHLORIDE
METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	Bryant Ranch Prepack	88af3365-1145-45a1-ab0f-1c794f0c13db	2023-05-24	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: METFORMIN HYDROCHLORIDE generic name: METFORMIN HYDROCHLORIDE
Metformin hydrochloride ER	METFORMIN HYDROCHLORIDE	Aphena Pharma Solutions - Tennessee, LLC	1ebaab3a-3d62-4c36-853f-c8784993eafb	2023-04-14	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: METFORMIN HYDROCHLORIDE
METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	Bryant Ranch Prepack	86627ff4-da1c-429d-991b-88e97f6967d6	2023-04-11	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: METFORMIN HYDROCHLORIDE generic name: METFORMIN HYDROCHLORIDE
METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	Bryant Ranch Prepack	8ce6b615-2abd-4a5b-997b-11aa1aec142d	2023-03-28	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: METFORMIN HYDROCHLORIDE generic name: METFORMIN HYDROCHLORIDE
METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	Golden State Medical Supply, Inc.	f86bda10-8b25-4125-8bb1-1b5917969ff0	2023-03-21	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: METFORMIN HYDROCHLORIDE generic name: METFORMIN HYDROCHLORIDE
Metformin Hydrochloride	METFORMIN HYDROCHLORIDE	A-S Medication Solutions	a57e2890-d83b-488c-b221-2e8f8a78ed16	2023-03-15	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Metformin Hydrochloride generic name: METFORMIN HYDROCHLORIDE
METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	Bryant Ranch Prepack	76879512-3ab4-4acf-92e6-bba0fb75dd0e	2023-03-10	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: METFORMIN HYDROCHLORIDE generic name: METFORMIN HYDROCHLORIDE
METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	Bryant Ranch Prepack	a59327bd-a3ba-417b-9e91-4cd3a941e640	2023-03-10	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: METFORMIN HYDROCHLORIDE generic name: METFORMIN HYDROCHLORIDE
METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	Bryant Ranch Prepack	a79d2674-071f-4641-9b11-406e02c5530a	2023-03-10	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: METFORMIN HYDROCHLORIDE generic name: METFORMIN HYDROCHLORIDE
METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	Bryant Ranch Prepack	93b0878d-b039-4479-8315-6dabf7e70611	2023-02-23	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: METFORMIN HYDROCHLORIDE generic name: METFORMIN HYDROCHLORIDE
Metformin Hydrochloride Extended-Release 500mg	METFORMIN HYDROCHLORIDE	Calvin Scott & Co., Inc.	e9cd0d23-56eb-40dd-abf4-9e681ec220f5	2023-02-07	Warnings	Name fallback generic name: METFORMIN HYDROCHLORIDE
Metformin hydrochloride	METFORMIN HYDROCHLORIDE	Macleods Pharmaceuticals Limited	623b3bc6-1b07-4a04-bc7a-7fc695adf063	2023-01-18	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Metformin hydrochloride generic name: METFORMIN HYDROCHLORIDE
Metformin Hydrochloride	METFORMIN HYDROCHLORIDE	Aphena Pharma Solutions - Tennessee, LLC	34aa1761-d16f-4bfc-b7fa-bf1b0387e8a3	2022-11-03	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Metformin Hydrochloride generic name: METFORMIN HYDROCHLORIDE
METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	Aphena Pharma Solutions - Tennessee, LLC	d0bee456-c8cd-46a1-acb3-5313a8cddd30	2022-11-03	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: METFORMIN HYDROCHLORIDE generic name: METFORMIN HYDROCHLORIDE
Metformin Hydrochloride	METFORMIN HYDROCHLORIDE	Proficient Rx LP	474e2900-43bf-4ebe-9d29-4a7adb8a9429	2022-11-01	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Metformin Hydrochloride generic name: METFORMIN HYDROCHLORIDE
Metformin Hydrochloride	METFORMIN HYDROCHLORIDE	Aphena Pharma Solutions - Tennessee, LLC	6b8824c0-ece0-4b15-ba71-e893d6d2bfdf	2022-07-15	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.

NDC Listings For This Application#

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

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
13668-013	Metformin Hydrochloride	metformin hydrochloride	Torrent Pharmaceuticals L	ANDA	Current