Application 075264

Type: ANDA
Sponsor: PERRIGO PHARMA INTL

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	TRETINOIN	TRETINOIN	CREAM;TOPICAL	0.025%	No	No

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
A075264-001	TRETINOIN	TRETINOIN	0.025%	CREAM / TOPICAL	AB		1998-12-24

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A075264-001	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 2 · 41 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
2026-02-19 14:30 UTC	2026-02	A075264-001	TRETINOIN	0.025%	CREAM / TOPICAL	AB	1998-12-24	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075264-001	TRETINOIN	0.025%	CREAM / TOPICAL	AB	1998-12-24	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075264-001	TRETINOIN	0.025%	CREAM / TOPICAL	AB	1998-12-24	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075264-001	TRETINOIN	0.025%	CREAM / TOPICAL	AB	1998-12-24	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075264-001	TRETINOIN	0.025%	CREAM / TOPICAL	AB	1998-12-24	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075264-001	TRETINOIN	0.025%	CREAM / TOPICAL	AB	1998-12-24	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075264-001	TRETINOIN	0.025%	CREAM / TOPICAL	AB	1998-12-24	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075264-001	TRETINOIN	0.025%	CREAM / TOPICAL	AB	1998-12-24	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075264-001	TRETINOIN	0.025%	CREAM / TOPICAL	AB	1998-12-24	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A075264-001	TRETINOIN	0.025%	CREAM / TOPICAL	AB	1998-12-24	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075264-001	TRETINOIN	0.025%	CREAM / TOPICAL	AB	1998-12-24	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075264-001	TRETINOIN	0.025%	CREAM / TOPICAL	AB	1998-12-24	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075264-001	TRETINOIN	0.025%	CREAM / TOPICAL	AB	1998-12-24	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A075264-001	TRETINOIN	0.025%	CREAM / TOPICAL	AB	1998-12-24	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075264-001	TRETINOIN	0.025%	CREAM / TOPICAL	AB	1998-12-24	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A075264-001	TRETINOIN	0.025%	CREAM / TOPICAL	AB	1998-12-24	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A075264-001	TRETINOIN	0.025%	CREAM / TOPICAL	AB	1998-12-24	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A075264-001	TRETINOIN	0.025%	CREAM / TOPICAL	AB	1998-12-24	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A075264-001	TRETINOIN	0.025%	CREAM / TOPICAL	AB	1998-12-24	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A075264-001	TRETINOIN	0.025%	CREAM / TOPICAL	AB	1998-12-24	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A075264-001	TRETINOIN	0.025%	CREAM / TOPICAL	AB	1998-12-24	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A075264-001	TRETINOIN	0.025%	CREAM / TOPICAL	AB	1998-12-24	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A075264-001	TRETINOIN	0.025%	CREAM / TOPICAL	AB	1998-12-24	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A075264-001	TRETINOIN	0.025%	CREAM / TOPICAL	AB	1998-12-24	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A075264-001	TRETINOIN	0.025%	CREAM / TOPICAL	AB	1998-12-24	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A075264-001	TRETINOIN	0.025%	CREAM / TOPICAL	AB	1998-12-24	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A075264-001	TRETINOIN	0.025%	CREAM / TOPICAL	AB	1998-12-24	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A075264-001	TRETINOIN	0.025%	CREAM / TOPICAL	AB	1998-12-24	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A075264-001	TRETINOIN	0.025%	CREAM / TOPICAL	AB	1998-12-24	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A075264-001	TRETINOIN	0.025%	CREAM / TOPICAL	AB	1998-12-24	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A075264-001	TRETINOIN	0.025%	CREAM / TOPICAL	AB	1998-12-24	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A075264-001	TRETINOIN	0.025%	CREAM / TOPICAL	AB	1998-12-24	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A075264-001	TRETINOIN	0.025%	CREAM / TOPICAL	AB	1998-12-24	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A075264-001	TRETINOIN	0.025%	CREAM / TOPICAL	AB	1998-12-24	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A075264-001	TRETINOIN	0.025%	CREAM / TOPICAL	AB	1998-12-24	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A075264-001	TRETINOIN	0.025%	CREAM / TOPICAL	AB	1998-12-24	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A075264-001	TRETINOIN	0.025%	CREAM / TOPICAL	AB	1998-12-24	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A075264-001	TRETINOIN	0.025%	CREAM / TOPICAL	AB	1998-12-24	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A075264-001	TRETINOIN	0.025%	CREAM / TOPICAL	AB	1998-12-24	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A075264-001	TRETINOIN	0.025%	CREAM / TOPICAL	AB	1998-12-24	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A075264-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075264-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075264-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075264-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075264-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075264-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075264-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075264-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075264-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A075264-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075264-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075264-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075264-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A075264-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075264-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A075264-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A075264-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A075264-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A075264-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A075264-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A075264-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A075264-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A075264-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A075264-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A075264-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A075264-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A075264-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A075264-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A075264-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A075264-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A075264-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A075264-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A075264-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A075264-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A075264-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A075264-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A075264-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A075264-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A075264-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A075264-001	AB	1	`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 · 5 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
TRETINOIN	TRETINOIN	Preferred Pharmaceuticals Inc.	d6819051-4748-479e-8b53-c298edcbd410	2026-01-28	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075264 application number: ANDA075264
TRETINOIN	TRETINOIN	NuCare Pharmaceuticals,Inc.	47fc341b-8cff-9d63-e063-6394a90abdfd	2026-01-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075264 application number: ANDA075264
TRETINOIN	TRETINOIN	Bryant Ranch Prepack	5e84c976-d4d6-4d8f-a448-8afb47e2fbff	2024-04-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075264 application number: ANDA075264
TRETINOIN	TRETINOIN	A-S Medication Solutions	0a6722ba-c2e5-4d7a-82ea-bcd6a54033b5	2024-01-28	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075264 application number: ANDA075264 ndc (product): 50090-3128
TRETINOIN	TRETINOIN	Padagis US LLC	4889c7f8-37d0-4f1a-9829-bca107806586	2023-12-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075264 application number: ANDA075264 ndc (product): 0574-2225

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 11 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0574-2225	TRETINOIN	tretinoin	Padagis US LLC	ANDA	Current
0574-2225	TRETINOIN	tretinoin	Padagis US LLC	ANDA	Current
0574-2225	TRETINOIN	tretinoin	Paddock Laboratories, LLC	ANDA	Current
0574-2225	TRETINOIN	tretinoin	Paddock Laboratories, LLC	ANDA	Current
0574-2225	TRETINOIN	tretinoin	Padagis US LLC	ANDA	Current
21695-655	Tretinoin	tretinoin	Rebel Distributors Corp	ANDA	Current
43478-243	Tretinoin	tretinoin	Rouses Point	ANDA	Current
50090-3128	TRETINOIN	tretinoin	A-S Medication Solutions	ANDA	Current
50090-3128	TRETINOIN	tretinoin	A-S Medication Solutions	ANDA	Current
53002-8101	TRETINOIN	tretinoin	RPK Pharmaceuticals, Inc.	ANDA	Current
69329-600	DERMAWERX ZMT PAK	ZINC OXIDE, MENTHOL, UNSPECIFIED FORM, and TRETINOIN	Patchwerx Labs, Inc.	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
22450	ORIG	2001-08-24
30825	ORIG	1998-12-24
18399	ORIG	1998-12-24