Application 077463

Type: ANDA
Sponsor: PAR PHARM

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	NATEGLINIDE	NATEGLINIDE	TABLET;ORAL	60MG	No	No
002	NATEGLINIDE	NATEGLINIDE	TABLET;ORAL	120MG	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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
A077463-001	NATEGLINIDE	NATEGLINIDE	60MG	TABLET / ORAL	AB		2009-09-09
A077463-002	NATEGLINIDE	NATEGLINIDE	120MG	TABLET / ORAL	AB		2009-09-09

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A077463-001	AB
A077463-002	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 3 · 84 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
2026-08-18 06:07:40	2026-07	A077463-001	NATEGLINIDE	60MG	TABLET / ORAL	AB	2009-09-09	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077463-002	NATEGLINIDE	120MG	TABLET / ORAL	AB	2009-09-09	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A077463-001	NATEGLINIDE	60MG	TABLET / ORAL	AB	2009-09-09	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077463-002	NATEGLINIDE	120MG	TABLET / ORAL	AB	2009-09-09	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077463-001	NATEGLINIDE	60MG	TABLET / ORAL	AB	2009-09-09	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077463-002	NATEGLINIDE	120MG	TABLET / ORAL	AB	2009-09-09	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077463-001	NATEGLINIDE	60MG	TABLET / ORAL	AB	2009-09-09	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077463-002	NATEGLINIDE	120MG	TABLET / ORAL	AB	2009-09-09	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077463-001	NATEGLINIDE	60MG	TABLET / ORAL	AB	2009-09-09	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077463-002	NATEGLINIDE	120MG	TABLET / ORAL	AB	2009-09-09	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077463-001	NATEGLINIDE	60MG	TABLET / ORAL	AB	2009-09-09	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077463-002	NATEGLINIDE	120MG	TABLET / ORAL	AB	2009-09-09	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077463-001	NATEGLINIDE	60MG	TABLET / ORAL	AB	2009-09-09	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077463-002	NATEGLINIDE	120MG	TABLET / ORAL	AB	2009-09-09	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077463-001	NATEGLINIDE	60MG	TABLET / ORAL	AB	2009-09-09	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077463-002	NATEGLINIDE	120MG	TABLET / ORAL	AB	2009-09-09	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077463-001	NATEGLINIDE	60MG	TABLET / ORAL	AB	2009-09-09	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077463-002	NATEGLINIDE	120MG	TABLET / ORAL	AB	2009-09-09	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077463-001	NATEGLINIDE	60MG	TABLET / ORAL	AB	2009-09-09	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077463-002	NATEGLINIDE	120MG	TABLET / ORAL	AB	2009-09-09	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A077463-001	NATEGLINIDE	60MG	TABLET / ORAL	AB	2009-09-09	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077463-002	NATEGLINIDE	120MG	TABLET / ORAL	AB	2009-09-09	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077463-001	NATEGLINIDE	60MG	TABLET / ORAL	AB	2009-09-09	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077463-002	NATEGLINIDE	120MG	TABLET / ORAL	AB	2009-09-09	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077463-001	NATEGLINIDE	60MG	TABLET / ORAL	AB	2009-09-09	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077463-002	NATEGLINIDE	120MG	TABLET / ORAL	AB	2009-09-09	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077463-001	NATEGLINIDE	60MG	TABLET / ORAL	AB	2009-09-09	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077463-002	NATEGLINIDE	120MG	TABLET / ORAL	AB	2009-09-09	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A077463-001	NATEGLINIDE	60MG	TABLET / ORAL	AB	2009-09-09	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A077463-002	NATEGLINIDE	120MG	TABLET / ORAL	AB	2009-09-09	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A077463-001	NATEGLINIDE	60MG	TABLET / ORAL	AB	2009-09-09	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A077463-002	NATEGLINIDE	120MG	TABLET / ORAL	AB	2009-09-09	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A077463-001	NATEGLINIDE	60MG	TABLET / ORAL	AB	2009-09-09	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A077463-002	NATEGLINIDE	120MG	TABLET / ORAL	AB	2009-09-09	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A077463-001	NATEGLINIDE	60MG	TABLET / ORAL	AB	2009-09-09	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A077463-002	NATEGLINIDE	120MG	TABLET / ORAL	AB	2009-09-09	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A077463-001	NATEGLINIDE	60MG	TABLET / ORAL	AB	2009-09-09	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A077463-002	NATEGLINIDE	120MG	TABLET / ORAL	AB	2009-09-09	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A077463-001	NATEGLINIDE	60MG	TABLET / ORAL	AB	2009-09-09	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A077463-002	NATEGLINIDE	120MG	TABLET / ORAL	AB	2009-09-09	`bb7c543d1eb4…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 84 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A077463-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077463-002	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A077463-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077463-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077463-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077463-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077463-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077463-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077463-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077463-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077463-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077463-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077463-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077463-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077463-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077463-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077463-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077463-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077463-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077463-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A077463-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077463-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077463-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077463-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077463-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077463-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077463-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077463-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A077463-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A077463-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A077463-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A077463-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A077463-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A077463-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A077463-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A077463-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A077463-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A077463-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A077463-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A077463-002	AB	1	`bb7c543d1eb4…`

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 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Nateglinide	NATEGLINIDE	Golden State Medical Supply, Inc.	e920b343-f53e-7487-e053-2995a90a719a	2025-04-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077463 application number: ANDA077463 ndc (product): 51407-656 ndc (product): 51407-657
Nateglinide	NATEGLINIDE	Strides Pharma Science Limited	0ccf9b07-3c21-482d-abeb-a06ceb482c7b	2025-02-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077463 application number: ANDA077463 ndc (product): 64380-167 ndc (product): 64380-168
Nateglinide	NATEGLINIDE	American Health Packaging	b17ead66-dc11-4e54-9ba6-00619510f27b	2025-01-07	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077463 application number: ANDA077463 ndc (product): 60687-673 ndc (product): 60687-684

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 40 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0615-7585	Nateglinide	Nateglinide	NCS HealthCare of KY, Inc dba Vangard Labs	ANDA	Current
0615-7586	Nateglinide	Nateglinide	NCS HealthCare of KY, Inc dba Vangard Labs	ANDA	Current
42291-636	Nateglinide	Nateglinide	AvKARE, Inc.	ANDA	Current
42291-636	Nateglinide	Nateglinide	AvKARE, Inc.	ANDA	Current
42291-636	Nateglinide	Nateglinide	AvKARE	ANDA	Current
42291-637	Nateglinide	Nateglinide	AvKARE, Inc.	ANDA	Current
42291-637	Nateglinide	Nateglinide	AvKARE, Inc.	ANDA	Current
42291-637	Nateglinide	Nateglinide	AvKARE	ANDA	Current
49884-984	Nateglinide	Nateglinide	Par Pharmaceutical, Inc.	ANDA	Current
49884-984	Nateglinide	Nateglinide	Par Pharmaceutical, Inc.	ANDA	Current
49884-984	Nateglinide	Nateglinide	Par Pharmaceutical, Inc.	ANDA	Current
49884-984	Nateglinide	Nateglinide	Par Pharmaceutical, Inc.	ANDA	Current
49884-985	Nateglinide	Nateglinide	Par Pharmaceutical, Inc.	ANDA	Current
49884-985	Nateglinide	Nateglinide	Par Pharmaceutical, Inc.	ANDA	Current
49884-985	Nateglinide	Nateglinide	Par Pharmaceutical, Inc.	ANDA	Current
49884-985	Nateglinide	Nateglinide	Par Pharmaceutical, Inc.	ANDA	Current
51407-656	Nateglinide	nateglinide	Golden State Medical Supply, Inc.	ANDA	Current
51407-657	Nateglinide	nateglinide	Golden State Medical Supply, Inc.	ANDA	Current
60429-434	Nateglinide	Nateglinide	Golden State Medical Supply, Inc.	ANDA	Current
60429-434	Nateglinide	Nateglinide	Golden State Medical Supply, Inc.	ANDA	Current
60429-435	Nateglinide	Nateglinide	Golden State Medical Supply, Inc.	ANDA	Current
60429-435	Nateglinide	Nateglinide	Golden State Medical Supply, Inc.	ANDA	Current
60687-673	Nateglinide	nateglinide	American Health Packaging	ANDA	Current
60687-673	Nateglinide	nateglinide	American Health Packaging	ANDA	Current
60687-684	Nateglinide	nateglinide	American Health Packaging	ANDA	Current
60687-684	Nateglinide	nateglinide	American Health Packaging	ANDA	Current
64380-167	Nateglinide	nateglinide	Strides Pharma Science Limited	ANDA	Current
64380-167	Nateglinide	nateglinide	Strides Pharma Science Limited	ANDA	Current
64380-168	Nateglinide	nateglinide	Strides Pharma Science Limited	ANDA	Current
64380-168	Nateglinide	nateglinide	Strides Pharma Science Limited	ANDA	Current
68084-458	Nateglinide	Nateglinide	American Health Packaging	ANDA	Current
68084-458	Nateglinide	Nateglinide	American Health Packaging	ANDA	Current
68084-458	Nateglinide	Nateglinide	American Health Packaging	ANDA	Current
68084-458	Nateglinide	Nateglinide	American Health Packaging	ANDA	Current
68084-458	Nateglinide	Nateglinide	American Health Packaging	ANDA	Current
68084-459	Nateglinide	Nateglinide	American Health Packaging	ANDA	Current
68084-459	Nateglinide	Nateglinide	American Health Packaging	ANDA	Current
68084-459	Nateglinide	Nateglinide	American Health Packaging	ANDA	Current
68084-459	Nateglinide	Nateglinide	American Health Packaging	ANDA	Current
68084-459	Nateglinide	Nateglinide	American Health Packaging	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
39531	ORIG	2009-10-21
31243	ORIG	2009-09-16
31242	ORIG	2006-08-14