Application 087165

Type: ANDA
Sponsor: ACP NIMBLE

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	PROMETHEGAN	PROMETHAZINE HYDROCHLORIDE	SUPPOSITORY;RECTAL	50MG	No	Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A087165-001	PROMETHEGAN	PROMETHAZINE HYDROCHLORIDE	50MG	SUPPOSITORY / RECTAL		RS	1987-08-14

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 2 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A087165-001	PROMETHEGAN	50MG	SUPPOSITORY / RECTAL	RS	1987-08-14	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A087165-001	PROMETHEGAN	50MG	SUPPOSITORY / RECTAL	RS	1987-08-14	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A087165-001	PROMETHEGAN	50MG	SUPPOSITORY / RECTAL	RS	1987-08-14	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A087165-001	PROMETHEGAN	50MG	SUPPOSITORY / RECTAL	RS	1987-08-14	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A087165-001	PROMETHEGAN	50MG	SUPPOSITORY / RECTAL	RS	1987-08-14	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A087165-001	PROMETHEGAN	50MG	SUPPOSITORY / RECTAL	RS	1987-08-14	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A087165-001	PROMETHEGAN	50MG	SUPPOSITORY / RECTAL	RS	1987-08-14	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A087165-001	PROMETHEGAN	50MG	SUPPOSITORY / RECTAL	RS	1987-08-14	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A087165-001	PROMETHEGAN	50MG	SUPPOSITORY / RECTAL	RS	1987-08-14	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A087165-001	PROMETHEGAN	50MG	SUPPOSITORY / RECTAL	RS	1987-08-14	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A087165-001	PROMETHEGAN	50MG	SUPPOSITORY / RECTAL	RS	1987-08-14	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A087165-001	PROMETHEGAN	50MG	SUPPOSITORY / RECTAL	RS	1987-08-14	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A087165-001	PROMETHEGAN	50MG	SUPPOSITORY / RECTAL	RS	1987-08-14	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A087165-001	PROMETHEGAN	50MG	SUPPOSITORY / RECTAL	RS	1987-08-14	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A087165-001	PROMETHEGAN	50MG	SUPPOSITORY / RECTAL	RS	1987-08-14	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A087165-001	PROMETHEGAN	50MG	SUPPOSITORY / RECTAL	RS	1987-08-14	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A087165-001	PROMETHEGAN	50MG	SUPPOSITORY / RECTAL	RS	1987-08-14	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A087165-001	PROMETHEGAN	50MG	SUPPOSITORY / RECTAL	RS	1987-08-14	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A087165-001	PROMETHEGAN	50MG	SUPPOSITORY / RECTAL	RS	1987-08-14	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A087165-001	PROMETHEGAN	50MG	SUPPOSITORY / RECTAL	RS	1987-08-14	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A087165-001	PROMETHEGAN	50MG	SUPPOSITORY / RECTAL	RS	1987-08-14	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A087165-001	PROMETHEGAN	50MG	SUPPOSITORY / RECTAL	RS	1987-08-14	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A087165-001	PROMETHEGAN	50MG	SUPPOSITORY / RECTAL	RS	1987-08-14	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A087165-001	PROMETHEGAN	50MG	SUPPOSITORY / RECTAL	RS	1987-08-14	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A087165-001	PROMETHEGAN	50MG	SUPPOSITORY / RECTAL	RS	1987-08-14	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A087165-001	PROMETHEGAN	50MG	SUPPOSITORY / RECTAL	RS	1987-08-14	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A087165-001	PROMETHEGAN	50MG	SUPPOSITORY / RECTAL	RS	1987-08-14	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A087165-001	PROMETHEGAN	50MG	SUPPOSITORY / RECTAL	RS	1987-08-14	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A087165-001	PROMETHEGAN	50MG	SUPPOSITORY / RECTAL	RS	1987-08-14	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A087165-001	PROMETHEGAN	50MG	SUPPOSITORY / RECTAL	RS	1987-08-14	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A087165-001	PROMETHEGAN	50MG	SUPPOSITORY / RECTAL	RS	1987-08-14	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A087165-001	PROMETHEGAN	50MG	SUPPOSITORY / RECTAL	RS	1987-08-14	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A087165-001	PROMETHEGAN	50MG	SUPPOSITORY / RECTAL	RS	1987-08-14	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A087165-001	PROMETHEGAN	50MG	SUPPOSITORY / RECTAL	RS	1987-08-14	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A087165-001	PROMETHEGAN	50MG	SUPPOSITORY / RECTAL	RS	1987-08-14	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A087165-001	PROMETHEGAN	50MG	SUPPOSITORY / RECTAL	RS	1987-08-14	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A087165-001	PROMETHEGAN	50MG	SUPPOSITORY / RECTAL	RS	1987-08-14	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A087165-001	PROMETHEGAN	50MG	SUPPOSITORY / RECTAL	RS	1987-08-14	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A087165-001	PROMETHEGAN	50MG	SUPPOSITORY / RECTAL	RS	1987-08-14	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A087165-001	PROMETHEGAN	50MG	SUPPOSITORY / RECTAL	RS	1987-08-14	`cb3db0bc1861…`

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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
PROMETHEGAN	PROMETHAZINE HYDROCHLORIDE	Cosette Pharmaceuticals, Inc.	636bb9bc-0cc5-4d6a-85be-6471acf01ffc	2023-11-30	Boxed warning, Adverse reactions	Exact identifier application applno (ANDA): 087165 application number: ANDA087165 ndc (product): 0713-0132

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 6 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0713-0132	PROMETHEGAN	promethazine hydrochloride	G&W Laboratories, Inc.	ANDA	Current
0713-0132	PROMETHEGAN	promethazine hydrochloride	Cosette Pharmaceuticals, Inc.	ANDA	Current
0713-0132	PROMETHEGAN	promethazine hydrochloride	Cosette Pharmaceuticals, Inc.	ANDA	Current
0713-0132	PROMETHEGAN	promethazine hydrochloride	Cosette Pharmaceuticals, Inc.	ANDA	Current
40085-220	Promethazine Hydrochloride	Promethazine Hydrochloride	Renaissance Pharma, Inc.	ANDA	Current
40085-220	Promethazine Hydrochloride	Promethazine Hydrochloride	Renaissance Pharma, Inc.	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
43204	ORIG	2011-05-06