Application 021748

Type: NDA
Sponsor: SANTARUS INC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	GLUMETZA	METFORMIN HYDROCHLORIDE	TABLET, EXTENDED RELEASE;ORAL	500MG	Yes	No
002	GLUMETZA	METFORMIN HYDROCHLORIDE	TABLET, EXTENDED RELEASE;ORAL	1GM	Yes	Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N021748-001	GLUMETZA	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE / ORAL		RLD	2005-06-03
N021748-002	GLUMETZA	METFORMIN HYDROCHLORIDE	1GM	TABLET, EXTENDED RELEASE / ORAL		RLD	2005-06-03

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 3 · 86 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	N021748-001	GLUMETZA	500MG	TABLET, EXTENDED RELEASE / ORAL		RLD	2005-06-03	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021748-002	GLUMETZA	1GM	TABLET, EXTENDED RELEASE / ORAL		RLD	2005-06-03	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N021748-001	GLUMETZA	500MG	TABLET, EXTENDED RELEASE / ORAL		RLD	2005-06-03	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021748-002	GLUMETZA	1GM	TABLET, EXTENDED RELEASE / ORAL		RLD	2005-06-03	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N021748-001	GLUMETZA	500MG	TABLET, EXTENDED RELEASE / ORAL		RLD	2005-06-03	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021748-002	GLUMETZA	1GM	TABLET, EXTENDED RELEASE / ORAL		RLD	2005-06-03	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021748-001	GLUMETZA	500MG	TABLET, EXTENDED RELEASE / ORAL		RLD	2005-06-03	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021748-002	GLUMETZA	1GM	TABLET, EXTENDED RELEASE / ORAL		RLD	2005-06-03	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021748-001	GLUMETZA	500MG	TABLET, EXTENDED RELEASE / ORAL	AB3	RLD	2005-06-03	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021748-002	GLUMETZA	1GM	TABLET, EXTENDED RELEASE / ORAL	AB3	RLD, RS	2005-06-03	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021748-001	GLUMETZA	500MG	TABLET, EXTENDED RELEASE / ORAL	AB3	RLD	2005-06-03	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021748-002	GLUMETZA	1GM	TABLET, EXTENDED RELEASE / ORAL	AB3	RLD, RS	2005-06-03	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021748-001	GLUMETZA	500MG	TABLET, EXTENDED RELEASE / ORAL	AB3	RLD	2005-06-03	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021748-002	GLUMETZA	1GM	TABLET, EXTENDED RELEASE / ORAL	AB3	RLD, RS	2005-06-03	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021748-001	GLUMETZA	500MG	TABLET, EXTENDED RELEASE / ORAL	AB3	RLD	2005-06-03	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021748-002	GLUMETZA	1GM	TABLET, EXTENDED RELEASE / ORAL	AB3	RLD, RS	2005-06-03	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021748-001	GLUMETZA	500MG	TABLET, EXTENDED RELEASE / ORAL	AB3	RLD	2005-06-03	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021748-002	GLUMETZA	1GM	TABLET, EXTENDED RELEASE / ORAL	AB3	RLD, RS	2005-06-03	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021748-001	GLUMETZA	500MG	TABLET, EXTENDED RELEASE / ORAL	AB3	RLD	2005-06-03	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021748-002	GLUMETZA	1GM	TABLET, EXTENDED RELEASE / ORAL	AB3	RLD, RS	2005-06-03	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021748-001	GLUMETZA	500MG	TABLET, EXTENDED RELEASE / ORAL	AB3	RLD	2005-06-03	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021748-002	GLUMETZA	1GM	TABLET, EXTENDED RELEASE / ORAL	AB3	RLD, RS	2005-06-03	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N021748-001	GLUMETZA	500MG	TABLET, EXTENDED RELEASE / ORAL	AB3	RLD	2005-06-03	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N021748-002	GLUMETZA	1GM	TABLET, EXTENDED RELEASE / ORAL	AB3	RLD, RS	2005-06-03	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021748-001	GLUMETZA	500MG	TABLET, EXTENDED RELEASE / ORAL	AB3	RLD	2005-06-03	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021748-002	GLUMETZA	1GM	TABLET, EXTENDED RELEASE / ORAL	AB3	RLD, RS	2005-06-03	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021748-001	GLUMETZA	500MG	TABLET, EXTENDED RELEASE / ORAL	AB3	RLD	2005-06-03	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021748-002	GLUMETZA	1GM	TABLET, EXTENDED RELEASE / ORAL	AB3	RLD, RS	2005-06-03	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021748-001	GLUMETZA	500MG	TABLET, EXTENDED RELEASE / ORAL	AB3	RLD	2005-06-03	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021748-002	GLUMETZA	1GM	TABLET, EXTENDED RELEASE / ORAL	AB3	RLD, RS	2005-06-03	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N021748-001	GLUMETZA	500MG	TABLET, EXTENDED RELEASE / ORAL	AB3	RLD	2005-06-03	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N021748-002	GLUMETZA	1GM	TABLET, EXTENDED RELEASE / ORAL	AB3	RLD, RS	2005-06-03	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021748-001	GLUMETZA	500MG	TABLET, EXTENDED RELEASE / ORAL	AB3	RLD	2005-06-03	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021748-002	GLUMETZA	1GM	TABLET, EXTENDED RELEASE / ORAL	AB3	RLD, RS	2005-06-03	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N021748-001	GLUMETZA	500MG	TABLET, EXTENDED RELEASE / ORAL	AB3	RLD	2005-06-03	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N021748-002	GLUMETZA	1GM	TABLET, EXTENDED RELEASE / ORAL	AB3	RLD, RS	2005-06-03	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N021748-001	GLUMETZA	500MG	TABLET, EXTENDED RELEASE / ORAL	AB3	RLD	2005-06-03	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N021748-002	GLUMETZA	1GM	TABLET, EXTENDED RELEASE / ORAL	AB3	RLD, RS	2005-06-03	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N021748-001	GLUMETZA	500MG	TABLET, EXTENDED RELEASE / ORAL	AB3	RLD	2005-06-03	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021748-002	GLUMETZA	1GM	TABLET, EXTENDED RELEASE / ORAL	AB3	RLD, RS	2005-06-03	`74a2ff9319b5…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 76 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2025-08-23 18:47 UTC	2025-08	N021748-001	AB3	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021748-002	AB3	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021748-001	AB3	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021748-002	AB3	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021748-001	AB3	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021748-002	AB3	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021748-001	AB3	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021748-002	AB3	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021748-001	AB3	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021748-002	AB3	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021748-001	AB3	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021748-002	AB3	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021748-001	AB3	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021748-002	AB3	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N021748-001	AB3	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N021748-002	AB3	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021748-001	AB3	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021748-002	AB3	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021748-001	AB3	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021748-002	AB3	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021748-001	AB3	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021748-002	AB3	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N021748-001	AB3	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N021748-002	AB3	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021748-001	AB3	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021748-002	AB3	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N021748-001	AB3	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N021748-002	AB3	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N021748-001	AB3	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N021748-002	AB3	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N021748-001	AB3	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021748-002	AB3	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N021748-001	AB3	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N021748-002	AB3	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N021748-001	AB3	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N021748-002	AB3	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021748-001	AB3	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021748-002	AB3	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N021748-001	AB3	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N021748-002	AB3	1	`5aa47cf7b7d7…`

Observed Orange Book patent history#

Patent history page 1 of 2 · 78 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Coverage / status	Submission date	Source SHA-256
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021748-002	7780987	2025-03-23	Drug substance, Drug product		`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021748-002	7780987	2025-03-23	Drug substance, Drug product		`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021748-002	7780987	2025-03-23	Drug substance, Drug product		`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021748-002	7780987	2025-03-23	Drug substance, Drug product		`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021748-002	7780987	2025-03-23	Drug substance, Drug product		`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021748-002	7780987	2025-03-23	Drug substance, Drug product		`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021748-002	7780987	2025-03-23	Drug substance, Drug product		`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021748-002	7780987	2025-03-23	Drug substance, Drug product		`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N021748-002	7780987	2025-03-23	Drug substance, Drug product		`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021748-002	7780987	2025-03-23	Drug substance, Drug product		`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021748-002	7780987	2025-03-23	Drug substance, Drug product		`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021748-002	7780987	2025-03-23	Drug substance, Drug product		`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N021748-002	7780987	2025-03-23	Drug substance, Drug product		`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021748-002	8323692	2023-03-30	Drug product	2012-12-12	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021748-002	7780987	2025-03-23	Drug substance, Drug product		`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N021748-002	8323692	2023-03-30	Drug product	2012-12-12	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N021748-002	7780987	2025-03-23	Drug substance, Drug product		`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N021748-002	8323692	2023-03-30	Drug product	2012-12-12	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N021748-002	7780987	2025-03-23	Drug substance, Drug product		`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N021748-001	6488962	2020-06-20	Drug substance, Drug product		`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021748-001	6723340	2021-10-25	Drug substance, Drug product		`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021748-002	8323692	2023-03-30	Drug product	2012-12-12	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021748-002	7780987	2025-03-23	Drug substance, Drug product		`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N021748-002	8323692	2023-03-30	Drug product	2012-12-12	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N021748-002	7780987	2025-03-23	Drug substance, Drug product		`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N021748-001	6723340	2021-10-25	Drug substance, Drug product		`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N021748-002	8323692	2023-03-30	Drug product	2012-12-12	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N021748-002	7780987	2025-03-23	Drug substance, Drug product		`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021748-001	6723340	2021-10-25	Drug substance, Drug product		`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021748-002	8323692	2023-03-30	Drug product	2012-12-12	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021748-002	7780987	2025-03-23	Drug substance, Drug product		`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N021748-001	6723340	2021-10-25	Drug substance, Drug product		`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N021748-002	8323692	2023-03-30	Drug product	2012-12-12	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N021748-002	7780987	2025-03-23	Drug substance, Drug product		`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N021748-001	6488962	2020-06-20	Drug substance, Drug product		`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N021748-001	6723340	2021-10-25	Drug substance, Drug product		`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N021748-002	8323692	2023-03-30	Drug product	2012-12-12	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N021748-002	7780987	2025-03-23	Drug substance, Drug product		`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N021748-001	6488962	2020-06-20	Drug substance, Drug product		`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N021748-001	6723340	2021-10-25	Drug substance, Drug product		`c0c555d07b60…`

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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Glumetza	METFORMIN HYDROCHLORIDE	Santarus, Inc.	fb832474-88d9-4e29-95cd-fbc446944cc4	2026-09-02	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 021748 application number: NDA021748 ndc (product): 68012-004 ndc (product): 68012-003 ndc (product): 68012-002
Metformin hydrochloride	METFORMIN HYDROCHLORIDE	Oceanside Pharmaceuticals	74d32a8a-c4c2-4dbb-b376-eea3f8fa64d7	2024-11-14	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 021748 application number: NDA021748 ndc (product): 68682-017 ndc (product): 68682-021 ndc (product): 68682-018

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 21 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
13913-002	Glumetza	metformin hydrochloride	Depomed, Inc.	NDA	Current
13913-003	Glumetza	metformin hydrochloride	Depomed, Inc.	NDA	Current
68012-002	Glumetza	metformin hydrochloride	Santarus, Inc.	NDA	Current
68012-002	Glumetza	metformin hydrochloride	Santarus, Inc.	NDA	Current
68012-002	Glumetza	metformin hydrochloride	Santarus, Inc.	NDA	Current
68012-002	Glumetza	metformin hydrochloride	Santarus, Inc.	NDA	Current
68012-003	Glumetza	metformin hydrochloride	Santarus, Inc.	NDA	Current
68012-003	Glumetza	metformin hydrochloride	Santarus, Inc.	NDA	Current
68012-003	Glumetza	metformin hydrochloride	Santarus, Inc.	NDA	Current
68012-003	Glumetza	metformin hydrochloride	Santarus, Inc.	NDA	Current
68012-004	Glumetza	metformin hydrochloride	Santarus, Inc.	NDA	Current
68012-004	Glumetza	metformin hydrochloride	Santarus, Inc.	NDA	Current
68012-004	Glumetza	metformin hydrochloride	Santarus, Inc.	NDA	Current
68012-004	Glumetza	metformin hydrochloride	Santarus, Inc.	NDA	Current
68682-017	Metformin hydrochloride	metformin hydrochloride	Oceanside Pharmaceuticals	NDA AUTHORIZED GENERIC	Current
68682-018	Metformin hydrochloride	metformin hydrochloride	Oceanside Pharmaceuticals	NDA AUTHORIZED GENERIC	Current
68682-018	Metformin hydrochloride	metformin hydrochloride	Oceanside Pharmaceuticals	NDA AUTHORIZED GENERIC	Current
68682-018	Metformin hydrochloride	metformin hydrochloride	Oceanside Pharmaceuticals	NDA AUTHORIZED GENERIC	Current
68682-021	Metformin hydrochloride	metformin hydrochloride	Oceanside Pharmaceuticals	NDA AUTHORIZED GENERIC	Current
68682-021	Metformin hydrochloride	metformin hydrochloride	Oceanside Pharmaceuticals	NDA AUTHORIZED GENERIC	Current
68682-021	Metformin hydrochloride	metformin hydrochloride	Oceanside Pharmaceuticals	NDA AUTHORIZED GENERIC	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
56459	SUPPL	2018-11-15
56400	SUPPL	2018-11-09
47927	SUPPL	2017-04-11
6111	SUPPL	2011-04-19
37577	SUPPL	2011-04-15
28515	SUPPL	2010-03-03
28514	SUPPL	2009-06-23
37576	SUPPL	2009-06-22
37575	SUPPL	2006-11-06
6110	SUPPL	2006-11-06
21802	ORIG	2006-09-07
28513	ORIG	2005-06-07
16302	ORIG	2005-06-07