Application 205330

Type: ANDA
Sponsor: MACLEODS PHARMS LTD

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 42.

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
A205330-001	METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	500MG	TABLET / ORAL	2017-10-31
A205330-002	METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	850MG	TABLET / ORAL	2017-10-31
A205330-003	METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	1GM	TABLET / ORAL	2017-10-31

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 · 126 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A205330-001	METFORMIN HYDROCHLORIDE	500MG	TABLET / ORAL	2017-10-31	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A205330-002	METFORMIN HYDROCHLORIDE	850MG	TABLET / ORAL	2017-10-31	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A205330-003	METFORMIN HYDROCHLORIDE	1GM	TABLET / ORAL	2017-10-31	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A205330-001	METFORMIN HYDROCHLORIDE	500MG	TABLET / ORAL	2017-10-31	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A205330-002	METFORMIN HYDROCHLORIDE	850MG	TABLET / ORAL	2017-10-31	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A205330-003	METFORMIN HYDROCHLORIDE	1GM	TABLET / ORAL	2017-10-31	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205330-001	METFORMIN HYDROCHLORIDE	500MG	TABLET / ORAL	2017-10-31	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205330-002	METFORMIN HYDROCHLORIDE	850MG	TABLET / ORAL	2017-10-31	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205330-003	METFORMIN HYDROCHLORIDE	1GM	TABLET / ORAL	2017-10-31	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A205330-001	METFORMIN HYDROCHLORIDE	500MG	TABLET / ORAL	2017-10-31	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A205330-002	METFORMIN HYDROCHLORIDE	850MG	TABLET / ORAL	2017-10-31	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A205330-003	METFORMIN HYDROCHLORIDE	1GM	TABLET / ORAL	2017-10-31	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205330-001	METFORMIN HYDROCHLORIDE	500MG	TABLET / ORAL	2017-10-31	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205330-002	METFORMIN HYDROCHLORIDE	850MG	TABLET / ORAL	2017-10-31	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205330-003	METFORMIN HYDROCHLORIDE	1GM	TABLET / ORAL	2017-10-31	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205330-001	METFORMIN HYDROCHLORIDE	500MG	TABLET / ORAL	2017-10-31	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205330-002	METFORMIN HYDROCHLORIDE	850MG	TABLET / ORAL	2017-10-31	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205330-003	METFORMIN HYDROCHLORIDE	1GM	TABLET / ORAL	2017-10-31	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205330-001	METFORMIN HYDROCHLORIDE	500MG	TABLET / ORAL	2017-10-31	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205330-002	METFORMIN HYDROCHLORIDE	850MG	TABLET / ORAL	2017-10-31	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205330-003	METFORMIN HYDROCHLORIDE	1GM	TABLET / ORAL	2017-10-31	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205330-001	METFORMIN HYDROCHLORIDE	500MG	TABLET / ORAL	2017-10-31	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205330-002	METFORMIN HYDROCHLORIDE	850MG	TABLET / ORAL	2017-10-31	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205330-003	METFORMIN HYDROCHLORIDE	1GM	TABLET / ORAL	2017-10-31	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205330-001	METFORMIN HYDROCHLORIDE	500MG	TABLET / ORAL	2017-10-31	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205330-002	METFORMIN HYDROCHLORIDE	850MG	TABLET / ORAL	2017-10-31	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205330-003	METFORMIN HYDROCHLORIDE	1GM	TABLET / ORAL	2017-10-31	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205330-001	METFORMIN HYDROCHLORIDE	500MG	TABLET / ORAL	2017-10-31	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205330-002	METFORMIN HYDROCHLORIDE	850MG	TABLET / ORAL	2017-10-31	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205330-003	METFORMIN HYDROCHLORIDE	1GM	TABLET / ORAL	2017-10-31	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A205330-001	METFORMIN HYDROCHLORIDE	500MG	TABLET / ORAL	2017-10-31	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A205330-002	METFORMIN HYDROCHLORIDE	850MG	TABLET / ORAL	2017-10-31	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A205330-003	METFORMIN HYDROCHLORIDE	1GM	TABLET / ORAL	2017-10-31	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A205330-001	METFORMIN HYDROCHLORIDE	500MG	TABLET / ORAL	2017-10-31	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A205330-002	METFORMIN HYDROCHLORIDE	850MG	TABLET / ORAL	2017-10-31	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A205330-003	METFORMIN HYDROCHLORIDE	1GM	TABLET / ORAL	2017-10-31	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A205330-001	METFORMIN HYDROCHLORIDE	500MG	TABLET / ORAL	2017-10-31	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A205330-002	METFORMIN HYDROCHLORIDE	850MG	TABLET / ORAL	2017-10-31	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A205330-003	METFORMIN HYDROCHLORIDE	1GM	TABLET / ORAL	2017-10-31	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A205330-001	METFORMIN HYDROCHLORIDE	500MG	TABLET / ORAL	2017-10-31	`1e350fbaab3a…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2019-12-13 00:20 UTC	2019-12	A205330-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A205330-002	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A205330-003	AB	1	`74a2ff9319b5…`
2019-12-14 00:12 UTC	2019-12	A205330-001	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A205330-002	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A205330-003	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A205330-001	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A205330-002	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A205330-003	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A205330-001	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A205330-002	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A205330-003	AB	1	`ea99ee380514…`

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	Macleods Pharmaceuticals Limited	623b3bc6-1b07-4a04-bc7a-7fc695adf063	2023-01-18	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205330 application number: ANDA205330 ndc (product): 33342-143 ndc (product): 33342-141 ndc (product): 33342-142

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 6 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
33342-141	Metformin Hydrochloride	Metformin Hydrochloride	Macleods Pharmaceuticals Limited	ANDA	Current
33342-141	Metformin hydrochloride	Metformin hydrochloride	Macleods Pharmaceuticals Limited	ANDA	Current
33342-142	Metformin Hydrochloride	Metformin Hydrochloride	Macleods Pharmaceuticals Limited	ANDA	Current
33342-142	Metformin hydrochloride	Metformin hydrochloride	Macleods Pharmaceuticals Limited	ANDA	Current
33342-143	Metformin Hydrochloride	Metformin Hydrochloride	Macleods Pharmaceuticals Limited	ANDA	Current
33342-143	Metformin hydrochloride	Metformin hydrochloride	Macleods Pharmaceuticals Limited	ANDA	Current