Application 077064

Type: ANDA
Sponsor: ZYDUS PHARMS USA

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	TABLET;ORAL	500MG	No	No
002	METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	TABLET;ORAL	850MG	No	No
003	METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	TABLET;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 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A077064-001	METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	500MG	TABLET / ORAL	AB	2005-04-18
A077064-002	METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	850MG	TABLET / ORAL	AB	2005-04-18
A077064-003	METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	1GM	TABLET / ORAL	AB	2005-04-18

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-product	TE code
A077064-001	AB
A077064-002	AB
A077064-003	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 4 · 129 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	A077064-001	METFORMIN HYDROCHLORIDE	500MG	TABLET / ORAL	AB	2005-04-18	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A077064-002	METFORMIN HYDROCHLORIDE	850MG	TABLET / ORAL	AB	2005-04-18	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A077064-003	METFORMIN HYDROCHLORIDE	1GM	TABLET / ORAL	AB	2005-04-18	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A077064-001	METFORMIN HYDROCHLORIDE	500MG	TABLET / ORAL	AB	2005-04-18	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077064-002	METFORMIN HYDROCHLORIDE	850MG	TABLET / ORAL	AB	2005-04-18	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077064-003	METFORMIN HYDROCHLORIDE	1GM	TABLET / ORAL	AB	2005-04-18	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A077064-001	METFORMIN HYDROCHLORIDE	500MG	TABLET / ORAL	AB	2005-04-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077064-002	METFORMIN HYDROCHLORIDE	850MG	TABLET / ORAL	AB	2005-04-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077064-003	METFORMIN HYDROCHLORIDE	1GM	TABLET / ORAL	AB	2005-04-18	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077064-001	METFORMIN HYDROCHLORIDE	500MG	TABLET / ORAL	AB	2005-04-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077064-002	METFORMIN HYDROCHLORIDE	850MG	TABLET / ORAL	AB	2005-04-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077064-003	METFORMIN HYDROCHLORIDE	1GM	TABLET / ORAL	AB	2005-04-18	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077064-001	METFORMIN HYDROCHLORIDE	500MG	TABLET / ORAL	AB	2005-04-18	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077064-002	METFORMIN HYDROCHLORIDE	850MG	TABLET / ORAL	AB	2005-04-18	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077064-003	METFORMIN HYDROCHLORIDE	1GM	TABLET / ORAL	AB	2005-04-18	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077064-001	METFORMIN HYDROCHLORIDE	500MG	TABLET / ORAL	AB	2005-04-18	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077064-002	METFORMIN HYDROCHLORIDE	850MG	TABLET / ORAL	AB	2005-04-18	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077064-003	METFORMIN HYDROCHLORIDE	1GM	TABLET / ORAL	AB	2005-04-18	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077064-001	METFORMIN HYDROCHLORIDE	500MG	TABLET / ORAL	AB	2005-04-18	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077064-002	METFORMIN HYDROCHLORIDE	850MG	TABLET / ORAL	AB	2005-04-18	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077064-003	METFORMIN HYDROCHLORIDE	1GM	TABLET / ORAL	AB	2005-04-18	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077064-001	METFORMIN HYDROCHLORIDE	500MG	TABLET / ORAL	AB	2005-04-18	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077064-002	METFORMIN HYDROCHLORIDE	850MG	TABLET / ORAL	AB	2005-04-18	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077064-003	METFORMIN HYDROCHLORIDE	1GM	TABLET / ORAL	AB	2005-04-18	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077064-001	METFORMIN HYDROCHLORIDE	500MG	TABLET / ORAL	AB	2005-04-18	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077064-002	METFORMIN HYDROCHLORIDE	850MG	TABLET / ORAL	AB	2005-04-18	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077064-003	METFORMIN HYDROCHLORIDE	1GM	TABLET / ORAL	AB	2005-04-18	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077064-001	METFORMIN HYDROCHLORIDE	500MG	TABLET / ORAL	AB	2005-04-18	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077064-002	METFORMIN HYDROCHLORIDE	850MG	TABLET / ORAL	AB	2005-04-18	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077064-003	METFORMIN HYDROCHLORIDE	1GM	TABLET / ORAL	AB	2005-04-18	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077064-001	METFORMIN HYDROCHLORIDE	500MG	TABLET / ORAL	AB	2005-04-18	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077064-002	METFORMIN HYDROCHLORIDE	850MG	TABLET / ORAL	AB	2005-04-18	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077064-003	METFORMIN HYDROCHLORIDE	1GM	TABLET / ORAL	AB	2005-04-18	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A077064-001	METFORMIN HYDROCHLORIDE	500MG	TABLET / ORAL	AB	2005-04-18	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077064-002	METFORMIN HYDROCHLORIDE	850MG	TABLET / ORAL	AB	2005-04-18	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077064-003	METFORMIN HYDROCHLORIDE	1GM	TABLET / ORAL	AB	2005-04-18	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077064-001	METFORMIN HYDROCHLORIDE	500MG	TABLET / ORAL	AB	2005-04-18	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077064-002	METFORMIN HYDROCHLORIDE	850MG	TABLET / ORAL	AB	2005-04-18	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077064-003	METFORMIN HYDROCHLORIDE	1GM	TABLET / ORAL	AB	2005-04-18	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077064-001	METFORMIN HYDROCHLORIDE	500MG	TABLET / ORAL	AB	2005-04-18	`301d65b070ca…`

Observed Orange Book normalized TE history#

Normalized TE history page 3 of 4 · 129 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2019-12-14 00:12 UTC	2019-12	A077064-003	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A077064-001	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A077064-002	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A077064-003	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A077064-001	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A077064-002	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A077064-003	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A077064-001	AB	1	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A077064-002	AB	1	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A077064-003	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A077064-001	AB	1	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A077064-002	AB	1	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A077064-003	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A077064-001	AB	1	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A077064-002	AB	1	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A077064-003	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A077064-001	AB	1	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A077064-002	AB	1	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A077064-003	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A077064-001	AB	1	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A077064-002	AB	1	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A077064-003	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A077064-001	AB	1	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A077064-002	AB	1	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A077064-003	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A077064-001	AB	1	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A077064-002	AB	1	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A077064-003	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A077064-001	AB	1	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	A077064-002	AB	1	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	A077064-003	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A077064-001	AB	1	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	A077064-002	AB	1	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	A077064-003	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A077064-001	AB	1	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A077064-002	AB	1	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A077064-003	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A077064-001	AB	1	`f41ea6bd6efb…`
2022-10-28 04:53 UTC	2022-10	A077064-002	AB	1	`f41ea6bd6efb…`
2022-10-28 04:53 UTC	2022-10	A077064-003	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 14 · 261 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.

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 34 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
10544-901	METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	Blenheim Pharmacal, Inc.	ANDA	Current
43063-507	METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	PD-Rx Pharmaceuticals, In	ANDA	Current
43063-507	METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
43063-507	METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
43353-098	METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	Aphena Pharma Solutions - Tennessee, LLC	ANDA	Current
43353-098	METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	Aphena Pharma Solutions - Tennessee, LLC	ANDA	Current
53808-0849	METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	State of Florida DOH Central Pharmacy	ANDA	Current
65841-028	METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	Cadila Healthcare Limited	ANDA	Current
65841-028	METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	Cadila Healthcare Limited	ANDA	Current
65841-028	METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	Cadila Healthcare Limited	ANDA	Current
65841-028	METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	Cadila Healthcare Limited	ANDA	Current
65841-028	METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	Zydus Lifesciences Limited	ANDA	Current
65841-028	METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	Cadila Healthcare Limited	ANDA	Current
65841-029	METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	Cadila Healthcare Limited	ANDA	Current
65841-029	METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	Cadila Healthcare Limited	ANDA	Current
65841-029	METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	Cadila Healthcare Limited	ANDA	Current
65841-029	METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	Cadila Healthcare Limited	ANDA	Current
65841-029	METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	Zydus Lifesciences Limited	ANDA	Current
65841-029	METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	Cadila Healthcare Limited	ANDA	Current
65841-030	METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	Cadila Healthcare Limited	ANDA	Current
65841-030	METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	Cadila Healthcare Limited	ANDA	Current
65841-030	METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	Cadila Healthcare Limited	ANDA	Current
65841-030	METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	Cadila Healthcare Limited	ANDA	Current
65841-030	METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	Zydus Lifesciences Limited	ANDA	Current
65841-030	METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	Cadila Healthcare Limited	ANDA	Current
67046-460	METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	Contract Pharmacy Services-PA	ANDA	Current
67046-461	METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	Contract Pharmacy Services-PA	ANDA	Current
67046-462	METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	Contract Pharmacy Services-PA	ANDA	Current
68382-028	METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-028	METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-029	METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-029	METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-030	METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-030	METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current