Application 077727

Type: ANDA
Sponsor: VINTAGE PHARMS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	HYDROCODONE BITARTRATE AND IBUPROFEN	HYDROCODONE BITARTRATE; IBUPROFEN	TABLET;ORAL	5MG;200MG	No	No

Source provenance: Browse the complete Orange Book source catalog.

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.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2019-12-13 00:20 UTC	2019-12	A077727-001	HYDROCODONE BITARTRATE AND IBUPROFEN	5MG;200MG	TABLET / ORAL	AB	2006-11-06	`74a2ff9319b5…`
2021-12-28 21:50 UTC	2021-12	A077727-001	HYDROCODONE BITARTRATE AND IBUPROFEN	5MG;200MG	TABLET / ORAL	AB	2006-11-06	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A077727-001	HYDROCODONE BITARTRATE AND IBUPROFEN	5MG;200MG	TABLET / ORAL	AB	2006-11-06	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A077727-001	HYDROCODONE BITARTRATE AND IBUPROFEN	5MG;200MG	TABLET / ORAL	AB	2006-11-06	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A077727-001	HYDROCODONE BITARTRATE AND IBUPROFEN	5MG;200MG	TABLET / ORAL	AB	2006-11-06	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A077727-001	HYDROCODONE BITARTRATE AND IBUPROFEN	5MG;200MG	TABLET / ORAL	AB	2006-11-06	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A077727-001	HYDROCODONE BITARTRATE AND IBUPROFEN	5MG;200MG	TABLET / ORAL	AB	2006-11-06	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A077727-001	HYDROCODONE BITARTRATE AND IBUPROFEN	5MG;200MG	TABLET / ORAL	AB	2006-11-06	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A077727-001	HYDROCODONE BITARTRATE AND IBUPROFEN	5MG;200MG	TABLET / ORAL	AB	2006-11-06	`ea99ee380514…`

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	A077727-001	AB	1	`74a2ff9319b5…`
2021-12-28 21:50 UTC	2021-12	A077727-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A077727-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A077727-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A077727-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A077727-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A077727-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A077727-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A077727-001	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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Hydrocodone Bitartrate and Ibuprofen	HYDROCODONE BITARTRATE AND IBUPROFEN	Aurolife Pharma, LLC	470df63a-5c0f-42df-9023-a330a901153e	2025-12-23	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Hydrocodone Bitartrate and Ibuprofen
Hydrocodone Bitartrate and Ibuprofen	HYDROCODONE BITARTRATE AND IBUPROFEN	Amneal Pharmaceuticals of New York LLC	abc33718-4e88-43ea-9ffa-2b04ffc812ef	2025-11-21	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Hydrocodone Bitartrate and Ibuprofen

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 · 3 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0603-3584	Hydrocodone Bitartrate and Ibuprofen	hydrocodone bitartrate and ibuprofen	Par Pharmaceutical	ANDA	Current
0603-3584	Hydrocodone Bitartrate and Ibuprofen	hydrocodone bitartrate and ibuprofen	Par Pharmaceutical	ANDA	Current
0603-3584	Hydrocodone Bitartrate and Ibuprofen	hydrocodone bitartrate and ibuprofen	Par Pharmaceutical	ANDA	Current