Application 091184

Type: ANDA
Sponsor: ALKEM

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 45.

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
A091184-001	METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	500MG	TABLET / ORAL	AB	2010-11-01
A091184-002	METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	850MG	TABLET / ORAL	AB	2010-11-01
A091184-003	METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	1GM	TABLET / ORAL	AB	2010-11-01

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A091184-001	AB
A091184-002	AB
A091184-003	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 · 135 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
2026-11-14 07:37:17	2026-10	A091184-001	METFORMIN HYDROCHLORIDE	500MG	TABLET / ORAL	AB	2010-11-01	`d4dbc9d85df4…`
2026-11-14 07:37:17	2026-10	A091184-002	METFORMIN HYDROCHLORIDE	850MG	TABLET / ORAL	AB	2010-11-01	`d4dbc9d85df4…`
2026-11-14 07:37:17	2026-10	A091184-003	METFORMIN HYDROCHLORIDE	1GM	TABLET / ORAL	AB	2010-11-01	`d4dbc9d85df4…`
2026-10-15 13:18:30	2026-09	A091184-001	METFORMIN HYDROCHLORIDE	500MG	TABLET / ORAL	AB	2010-11-01	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A091184-002	METFORMIN HYDROCHLORIDE	850MG	TABLET / ORAL	AB	2010-11-01	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A091184-003	METFORMIN HYDROCHLORIDE	1GM	TABLET / ORAL	AB	2010-11-01	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A091184-001	METFORMIN HYDROCHLORIDE	500MG	TABLET / ORAL	AB	2010-11-01	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A091184-002	METFORMIN HYDROCHLORIDE	850MG	TABLET / ORAL	AB	2010-11-01	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A091184-003	METFORMIN HYDROCHLORIDE	1GM	TABLET / ORAL	AB	2010-11-01	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A091184-001	METFORMIN HYDROCHLORIDE	500MG	TABLET / ORAL	AB	2010-11-01	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A091184-002	METFORMIN HYDROCHLORIDE	850MG	TABLET / ORAL	AB	2010-11-01	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A091184-003	METFORMIN HYDROCHLORIDE	1GM	TABLET / ORAL	AB	2010-11-01	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A091184-001	METFORMIN HYDROCHLORIDE	500MG	TABLET / ORAL	AB	2010-11-01	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A091184-002	METFORMIN HYDROCHLORIDE	850MG	TABLET / ORAL	AB	2010-11-01	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A091184-003	METFORMIN HYDROCHLORIDE	1GM	TABLET / ORAL	AB	2010-11-01	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091184-001	METFORMIN HYDROCHLORIDE	500MG	TABLET / ORAL	AB	2010-11-01	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091184-002	METFORMIN HYDROCHLORIDE	850MG	TABLET / ORAL	AB	2010-11-01	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091184-003	METFORMIN HYDROCHLORIDE	1GM	TABLET / ORAL	AB	2010-11-01	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A091184-001	METFORMIN HYDROCHLORIDE	500MG	TABLET / ORAL	AB	2010-11-01	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A091184-002	METFORMIN HYDROCHLORIDE	850MG	TABLET / ORAL	AB	2010-11-01	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A091184-003	METFORMIN HYDROCHLORIDE	1GM	TABLET / ORAL	AB	2010-11-01	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091184-001	METFORMIN HYDROCHLORIDE	500MG	TABLET / ORAL	AB	2010-11-01	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091184-002	METFORMIN HYDROCHLORIDE	850MG	TABLET / ORAL	AB	2010-11-01	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091184-003	METFORMIN HYDROCHLORIDE	1GM	TABLET / ORAL	AB	2010-11-01	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091184-001	METFORMIN HYDROCHLORIDE	500MG	TABLET / ORAL	AB	2010-11-01	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091184-002	METFORMIN HYDROCHLORIDE	850MG	TABLET / ORAL	AB	2010-11-01	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091184-003	METFORMIN HYDROCHLORIDE	1GM	TABLET / ORAL	AB	2010-11-01	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091184-001	METFORMIN HYDROCHLORIDE	500MG	TABLET / ORAL	AB	2010-11-01	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091184-002	METFORMIN HYDROCHLORIDE	850MG	TABLET / ORAL	AB	2010-11-01	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091184-003	METFORMIN HYDROCHLORIDE	1GM	TABLET / ORAL	AB	2010-11-01	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091184-001	METFORMIN HYDROCHLORIDE	500MG	TABLET / ORAL	AB	2010-11-01	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091184-002	METFORMIN HYDROCHLORIDE	850MG	TABLET / ORAL	AB	2010-11-01	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091184-003	METFORMIN HYDROCHLORIDE	1GM	TABLET / ORAL	AB	2010-11-01	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091184-001	METFORMIN HYDROCHLORIDE	500MG	TABLET / ORAL	AB	2010-11-01	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091184-002	METFORMIN HYDROCHLORIDE	850MG	TABLET / ORAL	AB	2010-11-01	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091184-003	METFORMIN HYDROCHLORIDE	1GM	TABLET / ORAL	AB	2010-11-01	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091184-001	METFORMIN HYDROCHLORIDE	500MG	TABLET / ORAL	AB	2010-11-01	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091184-002	METFORMIN HYDROCHLORIDE	850MG	TABLET / ORAL	AB	2010-11-01	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091184-003	METFORMIN HYDROCHLORIDE	1GM	TABLET / ORAL	AB	2010-11-01	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A091184-001	METFORMIN HYDROCHLORIDE	500MG	TABLET / ORAL	AB	2010-11-01	`d06236e962d9…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 135 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-11-14 07:37:17	2026-10	A091184-001	AB	1	`d4dbc9d85df4…`
2026-11-14 07:37:17	2026-10	A091184-002	AB	1	`d4dbc9d85df4…`
2026-11-14 07:37:17	2026-10	A091184-003	AB	1	`d4dbc9d85df4…`
2026-10-15 13:18:30	2026-09	A091184-001	AB	1	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A091184-002	AB	1	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A091184-003	AB	1	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A091184-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A091184-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A091184-003	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A091184-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A091184-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A091184-003	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A091184-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A091184-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A091184-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091184-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091184-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091184-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A091184-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A091184-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A091184-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091184-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091184-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091184-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091184-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091184-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091184-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091184-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091184-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091184-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091184-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091184-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091184-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091184-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091184-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091184-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091184-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091184-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091184-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A091184-001	AB	1	`d06236e962d9…`

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 7 of 12 · 240 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Metformin Hydrochloride	METFORMIN HYDROCHLORIDE	Preferred Pharmaceuticals Inc.	e55ee270-5eb9-4848-8529-9af2a79669c0	2025-07-31	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Metformin Hydrochloride generic name: METFORMIN HYDROCHLORIDE
Metformin Hydrochloride	METFORMIN HYDROCHLORIDE	Aphena Pharma Solutions - Tennessee, LLC	3ab4efb6-bd30-2583-e063-6294a90a415b	2025-07-24	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Metformin Hydrochloride generic name: METFORMIN HYDROCHLORIDE
METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	A-S Medication Solutions	72dbc087-9a84-4126-bf54-c5254a8b129c	2025-07-09	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: METFORMIN HYDROCHLORIDE generic name: METFORMIN HYDROCHLORIDE
METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	Aphena Pharma Solutions - Tennessee, LLC	3982b985-9184-0e17-e063-6394a90aae05	2025-07-09	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: METFORMIN HYDROCHLORIDE generic name: METFORMIN HYDROCHLORIDE
Metformin Hydrochloride	METFORMIN HYDROCHLORIDE	A-S Medication Solutions	bb62088f-e9af-4644-9f57-cb90bab0f199	2025-07-09	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Metformin Hydrochloride generic name: METFORMIN HYDROCHLORIDE
Metformin Hydrochloride	METFORMIN HYDROCHLORIDE	A-S Medication Solutions	59743092-bae1-4725-ac4b-c8a8b0a81c1e	2025-07-09	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Metformin Hydrochloride generic name: METFORMIN HYDROCHLORIDE
METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	Aphena Pharma Solutions - Tennessee, LLC	3890b116-7c3c-e48e-e063-6294a90a0c8a	2025-07-03	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: METFORMIN HYDROCHLORIDE generic name: METFORMIN HYDROCHLORIDE
Metformin Hydrochloride	METFORMIN HYDROCHLORIDE	Aphena Pharma Solutions - Tennessee, LLC	390c3bdf-bfaf-203e-e063-6394a90a7d20	2025-07-03	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Metformin Hydrochloride generic name: METFORMIN HYDROCHLORIDE
METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	A-S Medication Solutions	ec3a9070-3745-41fb-b610-8d06129d8fd9	2025-07-01	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: METFORMIN HYDROCHLORIDE generic name: METFORMIN HYDROCHLORIDE
METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	A-S Medication Solutions	51e1fe6e-a7fa-47a5-bbd5-73b275230c7f	2025-07-01	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: METFORMIN HYDROCHLORIDE generic name: METFORMIN HYDROCHLORIDE
METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	Westminster Pharmaceuticals, LLC	07b4ee2a-8435-4d38-a6b0-b919e3424153	2025-06-30	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: METFORMIN HYDROCHLORIDE generic name: METFORMIN HYDROCHLORIDE
METFORMIN HYDROCHLORIDE EXTENDED RELEASE	METFORMIN HYDROCHLORIDE	TIME CAP LABORATORIES, INC	1d8b8970-c2a1-4780-be87-ab8ccfd401fa	2025-06-30	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: METFORMIN HYDROCHLORIDE
METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	A-S Medication Solutions	0cd086d6-3ae2-476e-b93e-29055e67e8fc	2025-06-18	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: METFORMIN HYDROCHLORIDE generic name: METFORMIN HYDROCHLORIDE
METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	A-S Medication Solutions	a434b937-2648-4509-8ce8-94a28582ec77	2025-06-17	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: METFORMIN HYDROCHLORIDE generic name: METFORMIN HYDROCHLORIDE
METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	A-S Medication Solutions	784a6bbd-4f13-45ed-89c1-154b06721ed0	2025-06-17	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: METFORMIN HYDROCHLORIDE generic name: METFORMIN HYDROCHLORIDE
Metformin Hydrochloride	METFORMIN HYDROCHLORIDE	A-S Medication Solutions	f6581ce6-0f9f-4887-ae83-4c6ecde619f3	2025-06-17	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Metformin Hydrochloride generic name: METFORMIN HYDROCHLORIDE
METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	A-S Medication Solutions	9fed67ea-7a15-4634-80cf-c975b8812ebe	2025-06-11	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: METFORMIN HYDROCHLORIDE generic name: METFORMIN HYDROCHLORIDE
METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	A-S Medication Solutions	2d68fd88-c591-4577-a7c3-901338bdaf90	2025-06-11	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: METFORMIN HYDROCHLORIDE generic name: METFORMIN HYDROCHLORIDE
Metformin Hydrochloride	METFORMIN HYDROCHLORIDE	Bryant Ranch Prepack	52eecdbd-e07e-447f-bf38-b3c347b60662	2025-06-02	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Metformin Hydrochloride generic name: METFORMIN HYDROCHLORIDE
METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	Coupler LLC	33ec9f6e-16d9-40ba-e063-6294a90ae87b	2025-04-29	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 · 37 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0440-5739	Metformin Hydrochloride	Metformin Hydrochloride	Liberty Pharmaceuticals, Inc.	ANDA	Current
0440-5745	Metformin Hydrochloride	Metformin Hydrochloride	Liberty Pharmaceuticals, Inc.	ANDA	Current
0440-5746	Metformin Hydrochloride	Metformin Hydrochloride	Liberty Pharmaceuticals, Inc.	ANDA	Current
0904-6326	Metformin Hydrochloride	Metformin Hydrochloride	Major Pharmaceuticals	ANDA	Current
0904-6327	Metformin Hydrochloride	Metformin Hydrochloride	Major Pharmaceuticals	ANDA	Current
0904-6328	Metformin Hydrochloride	Metformin Hydrochloride	Major Pharmaceuticals	ANDA	Current
12634-756	Metformin Hydrochloride	Metformin Hydrochloride	Apotheca Inc.	ANDA	Current
12634-757	Metformin Hydrochloride	Metformin Hydrochloride	Apotheca Inc.	ANDA	Current
12634-789	Metformin Hydrochloride	Metformin Hydrochloride	Apotheca Inc.	ANDA	Current
42708-117	Metformin Hydrochloride	Metformin Hydrochloride	QPharma Inc	ANDA	Current
42708-117	Metformin Hydrochloride	Metformin Hydrochloride	QPharma Inc	ANDA	Current
43353-128	Metformin Hydrochloride	Metformin Hydrochloride	Aphena Pharma Solutions - Tennessee, LLC	ANDA	Current
50090-2410	Metformin Hydrochloride	Metformin Hydrochloride	A-S Medication Solutions	ANDA	Current
50090-2612	Metformin Hydrochloride	Metformin Hydrochloride	A-S Medication Solutions	ANDA	Current
50090-2635	Metformin Hydrochloride	Metformin Hydrochloride	A-S Medication Solutions	ANDA	Current
50090-3088	Metformin Hydrochloride	Metformin Hydrochloride	A-S Medication Solutions	ANDA	Current
53808-1033	Metformin Hydrochloride	Metformin Hydrochloride	State of Florida DOH Central Pharmacy	ANDA	Current
55154-5888	Metformin Hydrochloride	Metformin Hydrochloride	Cardinal Health	ANDA	Current
55154-5888	Metformin Hydrochloride	Metformin Hydrochloride	Cardinal Health	ANDA	Current
55700-475	Metformin Hydrochloride	Metformin Hydrochloride	Lake Erie Medical DBA Quality Care Products LLC	ANDA	Current
67877-217	Metformin Hydrochloride	Metformin Hydrochloride	Ascend Laboratories, LLC	ANDA	Current
67877-217	Metformin Hydrochloride	Metformin Hydrochloride	Ascend Laboratories, LLC	ANDA	Current
67877-217	Metformin Hydrochloride	Metformin Hydrochloride	Ascend Laboratories, LLC	ANDA	Current
67877-218	Metformin Hydrochloride	Metformin Hydrochloride	Ascend Laboratories, LLC	ANDA	Current
67877-218	Metformin Hydrochloride	Metformin Hydrochloride	Ascend Laboratories, LLC	ANDA	Current
67877-218	Metformin Hydrochloride	Metformin Hydrochloride	Ascend Laboratories, LLC	ANDA	Current
67877-221	Metformin Hydrochloride	Metformin Hydrochloride	Ascend Laboratories, LLC	ANDA	Current
67877-221	Metformin Hydrochloride	Metformin Hydrochloride	Ascend Laboratories, LLC	ANDA	Current
67877-221	Metformin Hydrochloride	Metformin Hydrochloride	Ascend Laboratories, LLC	ANDA	Current
68788-6982	Metformin Hydrochloride	Metformin Hydrochloride	Preferred Pharmaceuticals Inc.	ANDA	Current
68788-6982	Metformin Hydrochloride	Metformin Hydrochloride	Preferred Pharmaceuticals Inc.	ANDA	Current
68788-6982	Metformin Hydrochloride	Metformin Hydrochloride	Preferred Pharmaceuticals Inc.	ANDA	Current
68788-7069	Metformin Hydrochloride	Metformin Hydrochloride	Preferred Pharmaceuticals Inc.	ANDA	Current
68788-7069	Metformin Hydrochloride	Metformin Hydrochloride	Preferred Pharmaceuticals Inc.	ANDA	Current
68788-7069	Metformin Hydrochloride	Metformin Hydrochloride	Preferred Pharmaceuticals Inc.	ANDA	Current
70518-0672	Metformin Hydrochloride	Metformin Hydrochloride	REMEDYREPACK INC.	ANDA	Current
70882-125	Metformin Hydrochloride	Metformin Hydrochloride	Cambridge Therapeutics Technologies, LLC	ANDA	Current