Application 077677

Type: ANDA
Sponsor: WOCKHARDT LTD

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	PROPOXYPHENE NAPSYLATE AND ACETAMINOPHEN	ACETAMINOPHEN; PROPOXYPHENE NAPSYLATE	TABLET;ORAL	325MG;50MG	No	No
002	PROPOXYPHENE NAPSYLATE AND ACETAMINOPHEN	ACETAMINOPHEN; PROPOXYPHENE NAPSYLATE	TABLET;ORAL	650MG;100MG	No	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
A077677-001	PROPOXYPHENE NAPSYLATE AND ACETAMINOPHEN	ACETAMINOPHEN; PROPOXYPHENE NAPSYLATE	325MG;50MG	TABLET / ORAL			2007-03-16
A077677-002	PROPOXYPHENE NAPSYLATE AND ACETAMINOPHEN	ACETAMINOPHEN; PROPOXYPHENE NAPSYLATE	650MG;100MG	TABLET / ORAL			2007-03-16

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	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A077677-001	PROPOXYPHENE NAPSYLATE AND ACETAMINOPHEN	325MG;50MG	TABLET / ORAL	2007-03-16	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A077677-002	PROPOXYPHENE NAPSYLATE AND ACETAMINOPHEN	650MG;100MG	TABLET / ORAL	2007-03-16	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A077677-001	PROPOXYPHENE NAPSYLATE AND ACETAMINOPHEN	325MG;50MG	TABLET / ORAL	2007-03-16	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077677-002	PROPOXYPHENE NAPSYLATE AND ACETAMINOPHEN	650MG;100MG	TABLET / ORAL	2007-03-16	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A077677-001	PROPOXYPHENE NAPSYLATE AND ACETAMINOPHEN	325MG;50MG	TABLET / ORAL	2007-03-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077677-002	PROPOXYPHENE NAPSYLATE AND ACETAMINOPHEN	650MG;100MG	TABLET / ORAL	2007-03-16	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077677-001	PROPOXYPHENE NAPSYLATE AND ACETAMINOPHEN	325MG;50MG	TABLET / ORAL	2007-03-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077677-002	PROPOXYPHENE NAPSYLATE AND ACETAMINOPHEN	650MG;100MG	TABLET / ORAL	2007-03-16	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077677-001	PROPOXYPHENE NAPSYLATE AND ACETAMINOPHEN	325MG;50MG	TABLET / ORAL	2007-03-16	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077677-002	PROPOXYPHENE NAPSYLATE AND ACETAMINOPHEN	650MG;100MG	TABLET / ORAL	2007-03-16	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077677-001	PROPOXYPHENE NAPSYLATE AND ACETAMINOPHEN	325MG;50MG	TABLET / ORAL	2007-03-16	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077677-002	PROPOXYPHENE NAPSYLATE AND ACETAMINOPHEN	650MG;100MG	TABLET / ORAL	2007-03-16	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077677-001	PROPOXYPHENE NAPSYLATE AND ACETAMINOPHEN	325MG;50MG	TABLET / ORAL	2007-03-16	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077677-002	PROPOXYPHENE NAPSYLATE AND ACETAMINOPHEN	650MG;100MG	TABLET / ORAL	2007-03-16	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077677-001	PROPOXYPHENE NAPSYLATE AND ACETAMINOPHEN	325MG;50MG	TABLET / ORAL	2007-03-16	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077677-002	PROPOXYPHENE NAPSYLATE AND ACETAMINOPHEN	650MG;100MG	TABLET / ORAL	2007-03-16	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077677-001	PROPOXYPHENE NAPSYLATE AND ACETAMINOPHEN	325MG;50MG	TABLET / ORAL	2007-03-16	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077677-002	PROPOXYPHENE NAPSYLATE AND ACETAMINOPHEN	650MG;100MG	TABLET / ORAL	2007-03-16	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077677-001	PROPOXYPHENE NAPSYLATE AND ACETAMINOPHEN	325MG;50MG	TABLET / ORAL	2007-03-16	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077677-002	PROPOXYPHENE NAPSYLATE AND ACETAMINOPHEN	650MG;100MG	TABLET / ORAL	2007-03-16	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077677-001	PROPOXYPHENE NAPSYLATE AND ACETAMINOPHEN	325MG;50MG	TABLET / ORAL	2007-03-16	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077677-002	PROPOXYPHENE NAPSYLATE AND ACETAMINOPHEN	650MG;100MG	TABLET / ORAL	2007-03-16	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A077677-001	PROPOXYPHENE NAPSYLATE AND ACETAMINOPHEN	325MG;50MG	TABLET / ORAL	2007-03-16	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077677-002	PROPOXYPHENE NAPSYLATE AND ACETAMINOPHEN	650MG;100MG	TABLET / ORAL	2007-03-16	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077677-001	PROPOXYPHENE NAPSYLATE AND ACETAMINOPHEN	325MG;50MG	TABLET / ORAL	2007-03-16	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077677-002	PROPOXYPHENE NAPSYLATE AND ACETAMINOPHEN	650MG;100MG	TABLET / ORAL	2007-03-16	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077677-001	PROPOXYPHENE NAPSYLATE AND ACETAMINOPHEN	325MG;50MG	TABLET / ORAL	2007-03-16	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077677-002	PROPOXYPHENE NAPSYLATE AND ACETAMINOPHEN	650MG;100MG	TABLET / ORAL	2007-03-16	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077677-001	PROPOXYPHENE NAPSYLATE AND ACETAMINOPHEN	325MG;50MG	TABLET / ORAL	2007-03-16	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077677-002	PROPOXYPHENE NAPSYLATE AND ACETAMINOPHEN	650MG;100MG	TABLET / ORAL	2007-03-16	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A077677-001	PROPOXYPHENE NAPSYLATE AND ACETAMINOPHEN	325MG;50MG	TABLET / ORAL	2007-03-16	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A077677-002	PROPOXYPHENE NAPSYLATE AND ACETAMINOPHEN	650MG;100MG	TABLET / ORAL	2007-03-16	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A077677-001	PROPOXYPHENE NAPSYLATE AND ACETAMINOPHEN	325MG;50MG	TABLET / ORAL	2007-03-16	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A077677-002	PROPOXYPHENE NAPSYLATE AND ACETAMINOPHEN	650MG;100MG	TABLET / ORAL	2007-03-16	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A077677-001	PROPOXYPHENE NAPSYLATE AND ACETAMINOPHEN	325MG;50MG	TABLET / ORAL	2007-03-16	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A077677-002	PROPOXYPHENE NAPSYLATE AND ACETAMINOPHEN	650MG;100MG	TABLET / ORAL	2007-03-16	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A077677-001	PROPOXYPHENE NAPSYLATE AND ACETAMINOPHEN	325MG;50MG	TABLET / ORAL	2007-03-16	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A077677-002	PROPOXYPHENE NAPSYLATE AND ACETAMINOPHEN	650MG;100MG	TABLET / ORAL	2007-03-16	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A077677-001	PROPOXYPHENE NAPSYLATE AND ACETAMINOPHEN	325MG;50MG	TABLET / ORAL	2007-03-16	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A077677-002	PROPOXYPHENE NAPSYLATE AND ACETAMINOPHEN	650MG;100MG	TABLET / ORAL	2007-03-16	`74a2ff9319b5…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Documents#

Document, Submission type, Date table
Document	Submission type	Date
31276	SUPPL	2010-01-05