Application 079118

Type: ANDA
Sponsor: AUROBINDO PHARMA 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	500MG	No	No
002	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 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A079118-001	METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB1		2012-07-20
A079118-002	METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	750MG	TABLET, EXTENDED RELEASE / ORAL	AB		2012-07-20

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-product	TE code
A079118-001	AB1
A079118-002	AB

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 3 · 86 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
2026-09-14 22:38:34	2026-08	A079118-001	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2012-07-20	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A079118-002	METFORMIN HYDROCHLORIDE	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	2012-07-20	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A079118-001	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2012-07-20	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A079118-002	METFORMIN HYDROCHLORIDE	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	2012-07-20	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A079118-001	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2012-07-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A079118-002	METFORMIN HYDROCHLORIDE	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	2012-07-20	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A079118-001	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2012-07-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A079118-002	METFORMIN HYDROCHLORIDE	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	2012-07-20	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A079118-001	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2012-07-20	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A079118-002	METFORMIN HYDROCHLORIDE	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	2012-07-20	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A079118-001	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2012-07-20	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A079118-002	METFORMIN HYDROCHLORIDE	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	2012-07-20	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A079118-001	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2012-07-20	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A079118-002	METFORMIN HYDROCHLORIDE	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	2012-07-20	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A079118-001	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2012-07-20	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A079118-002	METFORMIN HYDROCHLORIDE	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	2012-07-20	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A079118-001	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2012-07-20	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A079118-002	METFORMIN HYDROCHLORIDE	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	2012-07-20	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A079118-001	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2012-07-20	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A079118-002	METFORMIN HYDROCHLORIDE	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	2012-07-20	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A079118-001	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2012-07-20	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A079118-002	METFORMIN HYDROCHLORIDE	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	2012-07-20	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A079118-001	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2012-07-20	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A079118-002	METFORMIN HYDROCHLORIDE	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	2012-07-20	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A079118-001	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2012-07-20	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A079118-002	METFORMIN HYDROCHLORIDE	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	2012-07-20	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A079118-001	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2012-07-20	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A079118-002	METFORMIN HYDROCHLORIDE	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	2012-07-20	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A079118-001	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2012-07-20	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A079118-002	METFORMIN HYDROCHLORIDE	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	2012-07-20	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A079118-001	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2012-07-20	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A079118-002	METFORMIN HYDROCHLORIDE	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	2012-07-20	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A079118-001	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2012-07-20	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A079118-002	METFORMIN HYDROCHLORIDE	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	2012-07-20	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A079118-001	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2012-07-20	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A079118-002	METFORMIN HYDROCHLORIDE	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	2012-07-20	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A079118-001	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2012-07-20	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A079118-002	METFORMIN HYDROCHLORIDE	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	2012-07-20	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A079118-001	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2012-07-20	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A079118-002	METFORMIN HYDROCHLORIDE	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	2012-07-20	`74a2ff9319b5…`

Observed Orange Book normalized TE history#

Normalized TE history page 2 of 3 · 86 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2022-03-09 01:35 UTC	2022-03	A079118-001	AB1	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A079118-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A079118-001	AB1	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A079118-002	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A079118-001	AB1	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A079118-002	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A079118-001	AB1	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A079118-002	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A079118-001	AB1	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A079118-002	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A079118-001	AB1	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A079118-002	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A079118-001	AB1	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A079118-002	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A079118-001	AB1	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A079118-002	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A079118-001	AB1	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A079118-002	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A079118-001	AB1	1	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A079118-002	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A079118-001	AB1	1	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A079118-002	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A079118-001	AB1	1	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A079118-002	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A079118-001	AB1	1	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A079118-002	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A079118-001	AB1	1	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A079118-002	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A079118-001	AB1	1	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A079118-002	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A079118-001	AB1	1	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A079118-002	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A079118-001	AB1	1	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	A079118-002	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A079118-001	AB1	1	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	A079118-002	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A079118-001	AB1	1	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A079118-002	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A079118-001	AB1	1	`f41ea6bd6efb…`
2022-10-28 04:53 UTC	2022-10	A079118-002	AB	1	`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 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Metformin Hydrochloride	METFORMIN HYDROCHLORIDE	Aurobindo Pharma Limited	8d4b8620-5e99-4d12-b4f2-e9967b627b57	2026-06-25	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 079118 application number: ANDA079118

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 · 12 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
57237-210	Metformin Hydrochloride	Metformin Hydrochloride	Citron Pharma LLC	ANDA	Current
57237-211	Metformin Hydrochloride	Metformin Hydrochloride	Citron Pharma LLC	ANDA	Current
65862-291	Metformin Hydrochloride	Metformin Hydrochloride	Aurobindo Pharma Limited	ANDA	Current
65862-291	Metformin Hydrochloride	Metformin Hydrochloride	Aurobindo Pharma Limited	ANDA	Current
65862-291	Metformin Hydrochloride	Metformin Hydrochloride	Aurobindo Pharma Limited	ANDA	Current
65862-291	Metformin Hydrochloride	Metformin Hydrochloride	Aurobindo Pharma Limited	ANDA	Current
65862-291	Metformin Hydrochloride	Metformin Hydrochloride	Aurobindo Pharma Limited	ANDA	Current
65862-292	Metformin Hydrochloride	Metformin Hydrochloride	Aurobindo Pharma Limited	ANDA	Current
65862-292	Metformin Hydrochloride	Metformin Hydrochloride	Aurobindo Pharma Limited	ANDA	Current
65862-292	Metformin Hydrochloride	Metformin Hydrochloride	Aurobindo Pharma Limited	ANDA	Current
65862-292	Metformin Hydrochloride	Metformin Hydrochloride	Aurobindo Pharma Limited	ANDA	Current
65862-292	Metformin Hydrochloride	Metformin Hydrochloride	Aurobindo Pharma Limited	ANDA	Current