Application 075985

Type: ANDA
Sponsor: SANDOZ

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 44.

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	Approval date
A075985-001	METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	500MG	TABLET / ORAL	2002-01-25
A075985-002	METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	850MG	TABLET / ORAL	2002-01-25
A075985-003	METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	1GM	TABLET / ORAL	2002-01-25

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 · 132 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-10-15 13:18:30	2026-09	A075985-001	METFORMIN HYDROCHLORIDE	500MG	TABLET / ORAL	2002-01-25	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A075985-002	METFORMIN HYDROCHLORIDE	850MG	TABLET / ORAL	2002-01-25	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A075985-003	METFORMIN HYDROCHLORIDE	1GM	TABLET / ORAL	2002-01-25	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A075985-001	METFORMIN HYDROCHLORIDE	500MG	TABLET / ORAL	2002-01-25	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A075985-002	METFORMIN HYDROCHLORIDE	850MG	TABLET / ORAL	2002-01-25	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A075985-003	METFORMIN HYDROCHLORIDE	1GM	TABLET / ORAL	2002-01-25	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A075985-001	METFORMIN HYDROCHLORIDE	500MG	TABLET / ORAL	2002-01-25	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A075985-002	METFORMIN HYDROCHLORIDE	850MG	TABLET / ORAL	2002-01-25	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A075985-003	METFORMIN HYDROCHLORIDE	1GM	TABLET / ORAL	2002-01-25	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A075985-001	METFORMIN HYDROCHLORIDE	500MG	TABLET / ORAL	2002-01-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075985-002	METFORMIN HYDROCHLORIDE	850MG	TABLET / ORAL	2002-01-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075985-003	METFORMIN HYDROCHLORIDE	1GM	TABLET / ORAL	2002-01-25	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075985-001	METFORMIN HYDROCHLORIDE	500MG	TABLET / ORAL	2002-01-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075985-002	METFORMIN HYDROCHLORIDE	850MG	TABLET / ORAL	2002-01-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075985-003	METFORMIN HYDROCHLORIDE	1GM	TABLET / ORAL	2002-01-25	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075985-001	METFORMIN HYDROCHLORIDE	500MG	TABLET / ORAL	2002-01-25	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075985-002	METFORMIN HYDROCHLORIDE	850MG	TABLET / ORAL	2002-01-25	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075985-003	METFORMIN HYDROCHLORIDE	1GM	TABLET / ORAL	2002-01-25	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075985-001	METFORMIN HYDROCHLORIDE	500MG	TABLET / ORAL	2002-01-25	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075985-002	METFORMIN HYDROCHLORIDE	850MG	TABLET / ORAL	2002-01-25	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075985-003	METFORMIN HYDROCHLORIDE	1GM	TABLET / ORAL	2002-01-25	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075985-001	METFORMIN HYDROCHLORIDE	500MG	TABLET / ORAL	2002-01-25	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075985-002	METFORMIN HYDROCHLORIDE	850MG	TABLET / ORAL	2002-01-25	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075985-003	METFORMIN HYDROCHLORIDE	1GM	TABLET / ORAL	2002-01-25	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075985-001	METFORMIN HYDROCHLORIDE	500MG	TABLET / ORAL	2002-01-25	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075985-002	METFORMIN HYDROCHLORIDE	850MG	TABLET / ORAL	2002-01-25	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075985-003	METFORMIN HYDROCHLORIDE	1GM	TABLET / ORAL	2002-01-25	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075985-001	METFORMIN HYDROCHLORIDE	500MG	TABLET / ORAL	2002-01-25	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075985-002	METFORMIN HYDROCHLORIDE	850MG	TABLET / ORAL	2002-01-25	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075985-003	METFORMIN HYDROCHLORIDE	1GM	TABLET / ORAL	2002-01-25	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075985-001	METFORMIN HYDROCHLORIDE	500MG	TABLET / ORAL	2002-01-25	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075985-002	METFORMIN HYDROCHLORIDE	850MG	TABLET / ORAL	2002-01-25	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075985-003	METFORMIN HYDROCHLORIDE	1GM	TABLET / ORAL	2002-01-25	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075985-001	METFORMIN HYDROCHLORIDE	500MG	TABLET / ORAL	2002-01-25	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075985-002	METFORMIN HYDROCHLORIDE	850MG	TABLET / ORAL	2002-01-25	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075985-003	METFORMIN HYDROCHLORIDE	1GM	TABLET / ORAL	2002-01-25	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A075985-001	METFORMIN HYDROCHLORIDE	500MG	TABLET / ORAL	2002-01-25	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A075985-002	METFORMIN HYDROCHLORIDE	850MG	TABLET / ORAL	2002-01-25	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A075985-003	METFORMIN HYDROCHLORIDE	1GM	TABLET / ORAL	2002-01-25	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075985-001	METFORMIN HYDROCHLORIDE	500MG	TABLET / ORAL	2002-01-25	`79d66fd596c7…`

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 9 of 13 · 251 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
METFORMIN HYDROCHLORIDE EXTENDED RELEASE	METFORMIN HYDROCHLORIDE	Proficient Rx LP	f1530d4f-21d9-4a4f-a814-07b180828ecd	2025-02-01	Warnings	Name fallback generic name: METFORMIN HYDROCHLORIDE
Metformin Hydrochloride	METFORMIN HYDROCHLORIDE	Proficient Rx LP	7cb47c3e-6657-4c11-8aa2-ae172e5a8529	2025-02-01	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Metformin Hydrochloride generic name: METFORMIN HYDROCHLORIDE
Metformin Hydrochloride	METFORMIN HYDROCHLORIDE	Lifsa Drugs, LLC	a2385bcd-0943-4411-8658-c22b50360385	2025-01-29	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Metformin Hydrochloride generic name: METFORMIN HYDROCHLORIDE
Metformin Hydrochloride	METFORMIN HYDROCHLORIDE	RedPharm Drug, Inc.	fc61bafa-a506-14ae-e053-6394a90a9c7d	2025-01-23	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Metformin Hydrochloride generic name: METFORMIN HYDROCHLORIDE
METFORMIN HYDROCHLORIDE EXTENDED RELEASE	METFORMIN HYDROCHLORIDE	direct rx	a84cf1a3-3820-cd1b-e053-2995a90acf45	2025-01-22	Warnings	Name fallback brand name: METFORMIN HYDROCHLORIDE generic name: METFORMIN HYDROCHLORIDE
METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	Preferred Pharmaceuticals Inc.	4adeddf2-f449-4a61-9658-dfbff7c50230	2025-01-21	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	27d6fdbc-27a8-c599-e063-6394a90a2233	2025-01-15	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: METFORMIN HYDROCHLORIDE
Metformin Hydrochloride	METFORMIN HYDROCHLORIDE	Preferred Pharmaceuticals Inc.	0f251f2c-97f3-4048-84f2-81fea03685aa	2025-01-15	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Metformin Hydrochloride generic name: METFORMIN HYDROCHLORIDE
Metformin Hydrochloride Oral Solution	METFORMIN HYDROCHLORIDE	TRUPHARMA, LLC	73691c6c-8841-4c5d-b4a5-c3ed3b5effa1	2024-12-27	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: METFORMIN HYDROCHLORIDE
Metformin Hydrochloride Oral Solution	METFORMIN HYDROCHLORIDE	Saptalis Pharmaceuticals, LLC.	df61d56e-18ff-404c-b671-42b39aa23574	2024-12-23	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: METFORMIN HYDROCHLORIDE
Metformin Hydrochloride	METFORMIN HYDROCHLORIDE	Bryant Ranch Prepack	286d959a-51cb-4dbd-a3e8-1ea2f00b54c7	2024-12-10	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Metformin Hydrochloride generic name: METFORMIN HYDROCHLORIDE
METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	NuCare Pharmaceuticals, Inc.	289dc8ec-42c8-1d09-e063-6394a90a97f0	2024-12-06	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: METFORMIN HYDROCHLORIDE generic name: METFORMIN HYDROCHLORIDE
METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	Zydus Lifesciences Limited	5043d03e-3c9d-4c96-b48d-187f02a1d27c	2024-12-05		Name fallback brand name: METFORMIN HYDROCHLORIDE generic name: METFORMIN HYDROCHLORIDE
Metformin Hydrochloride	METFORMIN HYDROCHLORIDE	A-S Medication Solutions	565610b8-a9a0-4e5e-866d-81d9501a817d	2024-11-15	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Metformin Hydrochloride generic name: METFORMIN HYDROCHLORIDE
Metformin Hydrochloride	METFORMIN HYDROCHLORIDE	A-S Medication Solutions	2d2ebf52-3d5e-4fad-b7f7-c9280957574c	2024-11-15	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Metformin Hydrochloride generic name: METFORMIN HYDROCHLORIDE
Metformin hydrochloride	METFORMIN HYDROCHLORIDE	Oceanside Pharmaceuticals	74d32a8a-c4c2-4dbb-b376-eea3f8fa64d7	2024-11-14	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Metformin hydrochloride generic name: METFORMIN HYDROCHLORIDE
Metformin Hydrochloride	METFORMIN HYDROCHLORIDE	A-S Medication Solutions	c2bbaa0c-5b05-4335-882f-14f1b443edd7	2024-10-14	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Metformin Hydrochloride generic name: METFORMIN HYDROCHLORIDE
Metformin Hydrochloride	METFORMIN HYDROCHLORIDE	A-S Medication Solutions	54ca16e6-1213-4877-8ace-477c764c8e76	2024-10-14	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Metformin Hydrochloride generic name: METFORMIN HYDROCHLORIDE
Metformin hydrochloride	METFORMIN HYDROCHLORIDE	Aphena Pharma Solutions - Tennessee, LLC	242538d7-fb79-4df6-e063-6394a90a5b96	2024-10-10	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Metformin hydrochloride generic name: METFORMIN HYDROCHLORIDE
Metformin Hydrochloride	METFORMIN HYDROCHLORIDE	American Health Packaging	dd54d30b-9390-4e5a-bf62-fbf18b91e4cd	2024-10-04	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 · 3 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
43353-340	Metformin Hydrochloride	Metformin Hydrochloride	Aphena Pharma Solutions - Tennessee, LLC	ANDA	Current
43353-344	Metformin Hydrochloride	Metformin Hydrochloride	Aphena Pharma Solutions - Tennessee, LLC	ANDA	Current
43353-349	Metformin Hydrochloride	Metformin Hydrochloride	Aphena Pharma Solutions - Tennessee, LLC	ANDA	Current