Application 021925

Type: NDA
Sponsor: TAKEDA PHARMS USA

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	DUETACT	GLIMEPIRIDE; PIOGLITAZONE HYDROCHLORIDE	TABLET;ORAL	2MG;30MG	Yes	Yes
002	DUETACT	GLIMEPIRIDE; PIOGLITAZONE HYDROCHLORIDE	TABLET;ORAL	4MG;30MG	Yes	No

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
N021925-001	DUETACT	GLIMEPIRIDE; PIOGLITAZONE HYDROCHLORIDE	2MG;30MG	TABLET / ORAL	AB	RLD, RS	2006-07-28
N021925-002	DUETACT	GLIMEPIRIDE; PIOGLITAZONE HYDROCHLORIDE	4MG;30MG	TABLET / ORAL	AB	RLD	2006-07-28

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-product	TE code
N021925-001	AB
N021925-002	AB

Orange Book patents#

Current patent rows page 1 of 1 · 4 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Coverage / status	Submission date
N021925-001	7700128	2027-01-30	Drug product
N021925-001	8071130	2028-06-08	Drug product	2011-12-15
N021925-002	7700128	2027-01-30	Drug product
N021925-002	8071130	2028-06-08	Drug product

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	N021925-001	DUETACT	2MG;30MG	TABLET / ORAL	AB	RLD, RS	2006-07-28	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021925-002	DUETACT	4MG;30MG	TABLET / ORAL	AB	RLD	2006-07-28	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N021925-001	DUETACT	2MG;30MG	TABLET / ORAL	AB	RLD, RS	2006-07-28	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021925-002	DUETACT	4MG;30MG	TABLET / ORAL	AB	RLD	2006-07-28	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N021925-001	DUETACT	2MG;30MG	TABLET / ORAL	AB	RLD, RS	2006-07-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021925-002	DUETACT	4MG;30MG	TABLET / ORAL	AB	RLD	2006-07-28	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021925-001	DUETACT	2MG;30MG	TABLET / ORAL	AB	RLD, RS	2006-07-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021925-002	DUETACT	4MG;30MG	TABLET / ORAL	AB	RLD	2006-07-28	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021925-001	DUETACT	2MG;30MG	TABLET / ORAL	AB	RLD, RS	2006-07-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021925-002	DUETACT	4MG;30MG	TABLET / ORAL	AB	RLD	2006-07-28	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021925-001	DUETACT	2MG;30MG	TABLET / ORAL	AB	RLD, RS	2006-07-28	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021925-002	DUETACT	4MG;30MG	TABLET / ORAL	AB	RLD	2006-07-28	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021925-001	DUETACT	2MG;30MG	TABLET / ORAL	AB	RLD, RS	2006-07-28	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021925-002	DUETACT	4MG;30MG	TABLET / ORAL	AB	RLD	2006-07-28	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021925-001	DUETACT	2MG;30MG	TABLET / ORAL	AB	RLD, RS	2006-07-28	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021925-002	DUETACT	4MG;30MG	TABLET / ORAL	AB	RLD	2006-07-28	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021925-001	DUETACT	2MG;30MG	TABLET / ORAL	AB	RLD, RS	2006-07-28	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021925-002	DUETACT	4MG;30MG	TABLET / ORAL	AB	RLD	2006-07-28	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021925-001	DUETACT	2MG;30MG	TABLET / ORAL	AB	RLD, RS	2006-07-28	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021925-002	DUETACT	4MG;30MG	TABLET / ORAL	AB	RLD	2006-07-28	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021925-001	DUETACT	2MG;30MG	TABLET / ORAL	AB	RLD, RS	2006-07-28	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021925-002	DUETACT	4MG;30MG	TABLET / ORAL	AB	RLD	2006-07-28	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N021925-001	DUETACT	2MG;30MG	TABLET / ORAL	AB	RLD, RS	2006-07-28	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N021925-002	DUETACT	4MG;30MG	TABLET / ORAL	AB	RLD	2006-07-28	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021925-001	DUETACT	2MG;30MG	TABLET / ORAL	AB	RLD, RS	2006-07-28	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021925-002	DUETACT	4MG;30MG	TABLET / ORAL	AB	RLD	2006-07-28	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021925-001	DUETACT	2MG;30MG	TABLET / ORAL	AB	RLD, RS	2006-07-28	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021925-002	DUETACT	4MG;30MG	TABLET / ORAL	AB	RLD	2006-07-28	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021925-001	DUETACT	2MG;30MG	TABLET / ORAL	AB	RLD, RS	2006-07-28	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021925-002	DUETACT	4MG;30MG	TABLET / ORAL	AB	RLD	2006-07-28	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N021925-001	DUETACT	2MG;30MG	TABLET / ORAL	AB	RLD, RS	2006-07-28	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N021925-002	DUETACT	4MG;30MG	TABLET / ORAL	AB	RLD	2006-07-28	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021925-001	DUETACT	2MG;30MG	TABLET / ORAL	AB	RLD, RS	2006-07-28	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021925-002	DUETACT	4MG;30MG	TABLET / ORAL	AB	RLD	2006-07-28	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N021925-001	DUETACT	2MG;30MG	TABLET / ORAL	AB	RLD, RS	2006-07-28	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N021925-002	DUETACT	4MG;30MG	TABLET / ORAL	AB	RLD	2006-07-28	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N021925-001	DUETACT	2MG;30MG	TABLET / ORAL	AB	RLD, RS	2006-07-28	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N021925-002	DUETACT	4MG;30MG	TABLET / ORAL	AB	RLD	2006-07-28	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N021925-001	DUETACT	2MG;30MG	TABLET / ORAL	AB	RLD, RS	2006-07-28	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021925-002	DUETACT	4MG;30MG	TABLET / ORAL	AB	RLD	2006-07-28	`74a2ff9319b5…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 86 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	N021925-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021925-002	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N021925-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021925-002	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N021925-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021925-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021925-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021925-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021925-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021925-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021925-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021925-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021925-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021925-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021925-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021925-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021925-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021925-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021925-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021925-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021925-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021925-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N021925-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N021925-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021925-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021925-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021925-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021925-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021925-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021925-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N021925-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N021925-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021925-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021925-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N021925-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N021925-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N021925-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N021925-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N021925-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021925-002	AB	1	`74a2ff9319b5…`

Observed Orange Book patent history#

Patent history page 4 of 5 · 172 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Coverage / status	Submission date	Source SHA-256
2024-02-18 07:12 UTC	2024-02	N021925-001	7700128	2027-01-30	Drug product		`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	N021925-001	8071130	2028-06-08	Drug product	2011-12-15	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	N021925-002	7700128	2027-01-30	Drug product		`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	N021925-002	8071130	2028-06-08	Drug product		`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N021925-001	7700128	2027-01-30	Drug product		`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	N021925-001	8071130	2028-06-08	Drug product	2011-12-15	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	N021925-002	7700128	2027-01-30	Drug product		`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	N021925-002	8071130	2028-06-08	Drug product		`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N021925-001	7700128	2027-01-30	Drug product		`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N021925-001	8071130	2028-06-08	Drug product	2011-12-15	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N021925-002	7700128	2027-01-30	Drug product		`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N021925-002	8071130	2028-06-08	Drug product		`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N021925-001	7700128	2027-01-30	Drug product		`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N021925-001	8071130	2028-06-08	Drug product	2011-12-15	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N021925-002	7700128	2027-01-30	Drug product		`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N021925-002	8071130	2028-06-08	Drug product		`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N021925-001	7700128	2027-01-30	Drug product		`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N021925-001	8071130	2028-06-08	Drug product	2011-12-15	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N021925-002	7700128	2027-01-30	Drug product		`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N021925-002	8071130	2028-06-08	Drug product		`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N021925-001	7700128	2027-01-30	Drug product		`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N021925-001	8071130	2028-06-08	Drug product	2011-12-15	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N021925-002	7700128	2027-01-30	Drug product		`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N021925-002	8071130	2028-06-08	Drug product		`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N021925-001	7700128	2027-01-30	Drug product		`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	N021925-001	8071130	2028-06-08	Drug product	2011-12-15	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	N021925-002	7700128	2027-01-30	Drug product		`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	N021925-002	8071130	2028-06-08	Drug product		`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N021925-001	7700128	2027-01-30	Drug product		`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	N021925-001	8071130	2028-06-08	Drug product	2011-12-15	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	N021925-002	7700128	2027-01-30	Drug product		`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	N021925-002	8071130	2028-06-08	Drug product		`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N021925-001	7700128	2027-01-30	Drug product		`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N021925-001	8071130	2028-06-08	Drug product	2011-12-15	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N021925-002	7700128	2027-01-30	Drug product		`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N021925-002	8071130	2028-06-08	Drug product		`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N021925-001	7700128	2027-01-30	Drug product		`f41ea6bd6efb…`
2022-10-28 04:53 UTC	2022-10	N021925-001	8071130	2028-06-08	Drug product	2011-12-15	`f41ea6bd6efb…`
2022-10-28 04:53 UTC	2022-10	N021925-002	7700128	2027-01-30	Drug product		`f41ea6bd6efb…`
2022-10-28 04:53 UTC	2022-10	N021925-002	8071130	2028-06-08	Drug product		`f41ea6bd6efb…`

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
pioglitazone and glimepiride	PIOGLITAZONE AND GLIMEPIRIDE	Prasco Laboratories	ea385b3d-cb4c-4550-97b0-93a86533f6dc	2025-12-12	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 021925 application number: NDA021925 ndc (product): 66993-821 ndc (product): 66993-822
Duetact	PIOGLITAZONE AND GLIMEPIRIDE	Takeda Pharmaceuticals America, Inc.	f8b0c917-3fdd-4a28-a47d-6225b8195458	2025-03-27	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 021925 application number: NDA021925 ndc (product): 64764-304 ndc (product): 64764-302

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 · 12 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
64764-302	Duetact	pioglitazone and glimepiride	Takeda Pharmaceuticals America, Inc.	NDA	Current
64764-302	Duetact	pioglitazone and glimepiride	Takeda Pharmaceuticals America, Inc.	NDA	Current
64764-302	Duetact	pioglitazone and glimepiride	Takeda Pharmaceuticals America, Inc.	NDA	Current
64764-302	Duetact	pioglitazone and glimepiride	Takeda Pharmaceuticals America, Inc.	NDA	Current
64764-304	Duetact	pioglitazone and glimepiride	Takeda Pharmaceuticals America, Inc.	NDA	Current
64764-304	Duetact	pioglitazone and glimepiride	Takeda Pharmaceuticals America, Inc.	NDA	Current
64764-304	Duetact	pioglitazone and glimepiride	Takeda Pharmaceuticals America, Inc.	NDA	Current
64764-304	Duetact	pioglitazone and glimepiride	Takeda Pharmaceuticals America, Inc.	NDA	Current
66993-821	pioglitazone and glimepiride	pioglitazone and glimepiride	Prasco Laboratories	NDA AUTHORIZED GENERIC	Current
66993-821	pioglitazone and glimepiride	pioglitazone and glimepiride	Prasco Laboratories	NDA AUTHORIZED GENERIC	Current
66993-822	pioglitazone and glimepiride	pioglitazone and glimepiride	Prasco Laboratories	NDA AUTHORIZED GENERIC	Current
66993-822	pioglitazone and glimepiride	pioglitazone and glimepiride	Prasco Laboratories	NDA AUTHORIZED GENERIC	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
50917	SUPPL	2017-12-27
50860	SUPPL	2017-12-26
50859	SUPPL	2017-12-26
46140	SUPPL	2016-12-13
37889	SUPPL	2015-03-19
28857	SUPPL	2015-03-17
28856	SUPPL	2013-11-14
28854	SUPPL	2013-11-14
16582	SUPPL	2013-11-14
16580	SUPPL	2013-11-14
6466	SUPPL	2012-05-22
37888	SUPPL	2011-08-04
28855	SUPPL	2011-08-04
16581	SUPPL	2011-08-04
6465	SUPPL	2011-08-04
37887	SUPPL	2010-09-29
6464	SUPPL	2010-09-28
6463	SUPPL	2009-10-26
28853	SUPPL	2009-01-06
16579	SUPPL	2009-01-06
21872	ORIG	2008-09-04
28852	SUPPL	2007-10-04
28851	SUPPL	2007-10-04
16578	SUPPL	2007-10-04
37886	SUPPL	2007-09-26
28850	SUPPL	2007-09-11
16577	SUPPL	2007-09-07
23684	ORIG	2007-08-15
37885	SUPPL	2007-02-23
6462	SUPPL	2007-02-12
37884	ORIG	2006-08-04
28849	ORIG	2006-08-04