Application 203686

Type: ANDA
Sponsor: ZYDUS HLTHCARE

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 1.

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
A203686-001	METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	500MG	TABLET / ORAL	AB	2014-08-28
A203686-002	METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	850MG	TABLET / ORAL	AB	2014-08-28
A203686-003	METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	1GM	TABLET / ORAL	AB	2014-08-28

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A203686-001	AB
A203686-002	AB
A203686-003	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 · 123 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
2026-02-19 14:30 UTC	2026-02	A203686-001	METFORMIN HYDROCHLORIDE	500MG	TABLET / ORAL	AB	2014-08-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203686-002	METFORMIN HYDROCHLORIDE	850MG	TABLET / ORAL	AB	2014-08-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203686-003	METFORMIN HYDROCHLORIDE	1GM	TABLET / ORAL	AB	2014-08-28	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203686-001	METFORMIN HYDROCHLORIDE	500MG	TABLET / ORAL	AB	2014-08-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203686-002	METFORMIN HYDROCHLORIDE	850MG	TABLET / ORAL	AB	2014-08-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203686-003	METFORMIN HYDROCHLORIDE	1GM	TABLET / ORAL	AB	2014-08-28	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A203686-001	METFORMIN HYDROCHLORIDE	500MG	TABLET / ORAL	AB	2014-08-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203686-002	METFORMIN HYDROCHLORIDE	850MG	TABLET / ORAL	AB	2014-08-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203686-003	METFORMIN HYDROCHLORIDE	1GM	TABLET / ORAL	AB	2014-08-28	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203686-001	METFORMIN HYDROCHLORIDE	500MG	TABLET / ORAL	AB	2014-08-28	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203686-002	METFORMIN HYDROCHLORIDE	850MG	TABLET / ORAL	AB	2014-08-28	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203686-003	METFORMIN HYDROCHLORIDE	1GM	TABLET / ORAL	AB	2014-08-28	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203686-001	METFORMIN HYDROCHLORIDE	500MG	TABLET / ORAL	AB	2014-08-28	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203686-002	METFORMIN HYDROCHLORIDE	850MG	TABLET / ORAL	AB	2014-08-28	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203686-003	METFORMIN HYDROCHLORIDE	1GM	TABLET / ORAL	AB	2014-08-28	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203686-001	METFORMIN HYDROCHLORIDE	500MG	TABLET / ORAL	AB	2014-08-28	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203686-002	METFORMIN HYDROCHLORIDE	850MG	TABLET / ORAL	AB	2014-08-28	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203686-003	METFORMIN HYDROCHLORIDE	1GM	TABLET / ORAL	AB	2014-08-28	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203686-001	METFORMIN HYDROCHLORIDE	500MG	TABLET / ORAL	AB	2014-08-28	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203686-002	METFORMIN HYDROCHLORIDE	850MG	TABLET / ORAL	AB	2014-08-28	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203686-003	METFORMIN HYDROCHLORIDE	1GM	TABLET / ORAL	AB	2014-08-28	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203686-001	METFORMIN HYDROCHLORIDE	500MG	TABLET / ORAL	AB	2014-08-28	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203686-002	METFORMIN HYDROCHLORIDE	850MG	TABLET / ORAL	AB	2014-08-28	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203686-003	METFORMIN HYDROCHLORIDE	1GM	TABLET / ORAL	AB	2014-08-28	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203686-001	METFORMIN HYDROCHLORIDE	500MG	TABLET / ORAL	AB	2014-08-28	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203686-002	METFORMIN HYDROCHLORIDE	850MG	TABLET / ORAL	AB	2014-08-28	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203686-003	METFORMIN HYDROCHLORIDE	1GM	TABLET / ORAL	AB	2014-08-28	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A203686-001	METFORMIN HYDROCHLORIDE	500MG	TABLET / ORAL	AB	2014-08-28	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A203686-002	METFORMIN HYDROCHLORIDE	850MG	TABLET / ORAL	AB	2014-08-28	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A203686-003	METFORMIN HYDROCHLORIDE	1GM	TABLET / ORAL	AB	2014-08-28	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203686-001	METFORMIN HYDROCHLORIDE	500MG	TABLET / ORAL	AB	2014-08-28	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203686-002	METFORMIN HYDROCHLORIDE	850MG	TABLET / ORAL	AB	2014-08-28	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203686-003	METFORMIN HYDROCHLORIDE	1GM	TABLET / ORAL	AB	2014-08-28	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203686-001	METFORMIN HYDROCHLORIDE	500MG	TABLET / ORAL	AB	2014-08-28	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203686-002	METFORMIN HYDROCHLORIDE	850MG	TABLET / ORAL	AB	2014-08-28	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203686-003	METFORMIN HYDROCHLORIDE	1GM	TABLET / ORAL	AB	2014-08-28	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203686-001	METFORMIN HYDROCHLORIDE	500MG	TABLET / ORAL	AB	2014-08-28	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203686-002	METFORMIN HYDROCHLORIDE	850MG	TABLET / ORAL	AB	2014-08-28	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203686-003	METFORMIN HYDROCHLORIDE	1GM	TABLET / ORAL	AB	2014-08-28	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A203686-001	METFORMIN HYDROCHLORIDE	500MG	TABLET / ORAL	AB	2014-08-28	`8072bd15b7f6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 123 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A203686-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203686-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203686-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203686-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203686-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203686-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A203686-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203686-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203686-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203686-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203686-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203686-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203686-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203686-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203686-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203686-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203686-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203686-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203686-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203686-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203686-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203686-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203686-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203686-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203686-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203686-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203686-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A203686-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A203686-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A203686-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203686-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203686-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203686-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203686-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203686-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203686-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203686-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203686-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203686-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A203686-001	AB	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 1 of 1 · 4 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	Quallent Pharmaceuticals Health LLC	25be863d-490c-47f6-9ad3-c828dc43fbf0	2026-06-11	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203686 application number: ANDA203686
METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	Zydus Pharmaceuticals USA Inc.	c82a10fa-1e8e-46b6-890a-737de3f34ee1	2026-06-10	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203686 application number: ANDA203686 ndc (product): 68382-759 ndc (product): 68382-758 ndc (product): 68382-760
METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	Zydus Lifesciences Limited	5043d03e-3c9d-4c96-b48d-187f02a1d27c	2024-12-05		Exact identifier application applno (ANDA): 203686 application number: ANDA203686 ndc (product): 65841-809 ndc (product): 65841-811 ndc (product): 65841-810
Metformin Hydrochloride	METFORMIN HYDROCHLORIDE	American Health Packaging	dd54d30b-9390-4e5a-bf62-fbf18b91e4cd	2024-10-04	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203686 application number: ANDA203686 ndc (product): 60687-162 ndc (product): 60687-143 ndc (product): 60687-155

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 50 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
10544-957	METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	Blenheim Pharmacal, Inc.	ANDA	Current
50090-3543	METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	A-S Medication Solutions	ANDA	Current
55154-4675	METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	Cardinal Health	ANDA	Current
60687-143	METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	American Health Packaging	ANDA	Current
60687-143	Metformin Hydrochloride	Metformin Hydrochloride	American Health Packaging	ANDA	Current
60687-143	Metformin Hydrochloride	Metformin Hydrochloride	American Health Packaging	ANDA	Current
60687-143	Metformin Hydrochloride	Metformin Hydrochloride	American Health Packaging	ANDA	Current
60687-143	Metformin Hydrochloride	Metformin Hydrochloride	American Health Packaging	ANDA	Current
60687-155	METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	American Health Packaging	ANDA	Current
60687-155	Metformin Hydrochloride	Metformin Hydrochloride	American Health Packaging	ANDA	Current
60687-155	Metformin Hydrochloride	Metformin Hydrochloride	American Health Packaging	ANDA	Current
60687-155	Metformin Hydrochloride	Metformin Hydrochloride	American Health Packaging	ANDA	Current
60687-155	Metformin Hydrochloride	Metformin Hydrochloride	American Health Packaging	ANDA	Current
60687-162	METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	American Health Packaging	ANDA	Current
60687-162	Metformin Hydrochloride	Metformin Hydrochloride	American Health Packaging	ANDA	Current
60687-162	Metformin Hydrochloride	Metformin Hydrochloride	American Health Packaging	ANDA	Current
60687-162	Metformin Hydrochloride	Metformin Hydrochloride	American Health Packaging	ANDA	Current
60687-162	Metformin Hydrochloride	Metformin Hydrochloride	American Health Packaging	ANDA	Current
63739-702	METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	McKesson Corporation dba SKY Packaging	ANDA	Current
63739-702	METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	McKesson Corporation	ANDA	Current
65841-809	METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	Cadila Healthcare Limited	ANDA	Current
65841-809	METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	Cadila Healthcare Limited	ANDA	Current
65841-809	METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	Cadila Healthcare Limited	ANDA	Current
65841-809	METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	Zydus Lifesciences Limited	ANDA	Current
65841-809	METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	Cadila Healthcare Limited	ANDA	Current
65841-810	METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	Cadila Healthcare Limited	ANDA	Current
65841-810	METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	Cadila Healthcare Limited	ANDA	Current
65841-810	METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	Cadila Healthcare Limited	ANDA	Current
65841-810	METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	Zydus Lifesciences Limited	ANDA	Current
65841-810	METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	Cadila Healthcare Limited	ANDA	Current
65841-811	METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	Cadila Healthcare Limited	ANDA	Current
65841-811	METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	Cadila Healthcare Limited	ANDA	Current
65841-811	METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	Cadila Healthcare Limited	ANDA	Current
65841-811	METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	Zydus Lifesciences Limited	ANDA	Current
65841-811	METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	Cadila Healthcare Limited	ANDA	Current
68071-3370	METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	NuCare Pharmaceuticals, Inc.	ANDA	Current
68382-758	METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-758	METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-758	METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	Zydus Pharmaceuticals USA Inc.	ANDA	Current
68382-759	METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-759	METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-759	METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	Zydus Pharmaceuticals USA Inc.	ANDA	Current
68382-760	METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-760	METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-760	METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	Zydus Pharmaceuticals USA Inc.	ANDA	Current
68645-539	METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	Legacy Pharmaceutical Packaging, LLC	ANDA	Current
68645-539	METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	Legacy Pharmaceutical Packaging, LLC	ANDA	Current
68645-539	METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	Legacy Pharmaceutical Packaging, LLC	ANDA	Current
68645-549	METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	Legacy Pharmaceutical Packaging, LLC	ANDA	Current
68645-549	METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	Legacy Pharmaceutical Packaging, LLC	ANDA	Current