Application 050802

Type: NDA
Sponsor: MEDICIS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	ZIANA	CLINDAMYCIN PHOSPHATE; TRETINOIN	GEL;TOPICAL	1.2%;0.025%	Yes	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
N050802-001	ZIANA	CLINDAMYCIN PHOSPHATE; TRETINOIN	1.2%;0.025%	GEL / TOPICAL	AB1	RLD, RS	2006-11-07

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
N050802-001	AB1

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	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N050802-001	ZIANA	1.2%;0.025%	GEL / TOPICAL	AB1	RLD, RS	2006-11-07	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N050802-001	ZIANA	1.2%;0.025%	GEL / TOPICAL	AB1	RLD, RS	2006-11-07	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N050802-001	ZIANA	1.2%;0.025%	GEL / TOPICAL	AB1	RLD, RS	2006-11-07	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N050802-001	ZIANA	1.2%;0.025%	GEL / TOPICAL	AB1	RLD, RS	2006-11-07	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N050802-001	ZIANA	1.2%;0.025%	GEL / TOPICAL	AB1	RLD, RS	2006-11-07	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N050802-001	ZIANA	1.2%;0.025%	GEL / TOPICAL	AB1	RLD, RS	2006-11-07	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N050802-001	ZIANA	1.2%;0.025%	GEL / TOPICAL	AB1	RLD, RS	2006-11-07	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N050802-001	ZIANA	1.2%;0.025%	GEL / TOPICAL	AB1	RLD, RS	2006-11-07	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N050802-001	ZIANA	1.2%;0.025%	GEL / TOPICAL	AB1	RLD, RS	2006-11-07	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N050802-001	ZIANA	1.2%;0.025%	GEL / TOPICAL	AB1	RLD, RS	2006-11-07	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N050802-001	ZIANA	1.2%;0.025%	GEL / TOPICAL	AB1	RLD, RS	2006-11-07	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N050802-001	ZIANA	1.2%;0.025%	GEL / TOPICAL	AB1	RLD, RS	2006-11-07	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N050802-001	ZIANA	1.2%;0.025%	GEL / TOPICAL	AB1	RLD, RS	2006-11-07	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N050802-001	ZIANA	1.2%;0.025%	GEL / TOPICAL	AB1	RLD, RS	2006-11-07	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N050802-001	ZIANA	1.2%;0.025%	GEL / TOPICAL	AB1	RLD, RS	2006-11-07	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N050802-001	ZIANA	1.2%;0.025%	GEL / TOPICAL	AB1	RLD, RS	2006-11-07	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N050802-001	ZIANA	1.2%;0.025%	GEL / TOPICAL	AB1	RLD, RS	2006-11-07	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N050802-001	ZIANA	1.2%;0.025%	GEL / TOPICAL	AB	RLD, RS	2006-11-07	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N050802-001	ZIANA	1.2%;0.025%	GEL / TOPICAL	AB	RLD, RS	2006-11-07	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N050802-001	ZIANA	1.2%;0.025%	GEL / TOPICAL	AB	RLD, RS	2006-11-07	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N050802-001	ZIANA	1.2%;0.025%	GEL / TOPICAL	AB	RLD, RS	2006-11-07	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N050802-001	ZIANA	1.2%;0.025%	GEL / TOPICAL	AB	RLD, RS	2006-11-07	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N050802-001	ZIANA	1.2%;0.025%	GEL / TOPICAL	AB	RLD, RS	2006-11-07	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N050802-001	ZIANA	1.2%;0.025%	GEL / TOPICAL	AB	RLD, RS	2006-11-07	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N050802-001	ZIANA	1.2%;0.025%	GEL / TOPICAL	AB	RLD, RS	2006-11-07	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N050802-001	ZIANA	1.2%;0.025%	GEL / TOPICAL	AB	RLD, RS	2006-11-07	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N050802-001	ZIANA	1.2%;0.025%	GEL / TOPICAL	AB	RLD, RS	2006-11-07	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N050802-001	ZIANA	1.2%;0.025%	GEL / TOPICAL	AB1	RLD, RS	2006-11-07	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N050802-001	ZIANA	1.2%;0.025%	GEL / TOPICAL	AB1	RLD, RS	2006-11-07	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N050802-001	ZIANA	1.2%;0.025%	GEL / TOPICAL	AB1	RLD, RS	2006-11-07	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N050802-001	ZIANA	1.2%;0.025%	GEL / TOPICAL	AB1	RLD, RS	2006-11-07	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N050802-001	ZIANA	1.2%;0.025%	GEL / TOPICAL	AB1	RLD, RS	2006-11-07	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N050802-001	ZIANA	1.2%;0.025%	GEL / TOPICAL	AB1	RLD, RS	2006-11-07	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N050802-001	ZIANA	1.2%;0.025%	GEL / TOPICAL	AB1	RLD, RS	2006-11-07	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N050802-001	ZIANA	1.2%;0.025%	GEL / TOPICAL	AB1	RLD, RS	2006-11-07	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N050802-001	ZIANA	1.2%;0.025%	GEL / TOPICAL	AB1	RLD, RS	2006-11-07	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N050802-001	ZIANA	1.2%;0.025%	GEL / TOPICAL	AB1	RLD, RS	2006-11-07	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N050802-001	ZIANA	1.2%;0.025%	GEL / TOPICAL	AB1	RLD, RS	2006-11-07	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N050802-001	ZIANA	1.2%;0.025%	GEL / TOPICAL	AB1	RLD, RS	2006-11-07	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N050802-001	ZIANA	1.2%;0.025%	GEL / TOPICAL	AB1	RLD, RS	2006-11-07	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

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

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N050802-001	AB1	1	`a50c72e98297…`

Observed Orange Book patent history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Source SHA-256
2019-12-13 00:20 UTC	2019-12	N050802-001	6387383	2020-08-03	U-916	Drug product	`74a2ff9319b5…`
2020-12-22 03:56 UTC	2020-12	N050802-001	6387383	2020-08-03	U-916	Drug product	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N050802-001	6387383	2020-08-03	U-916	Drug product	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N050802-001	6387383	2020-08-03	U-916	Drug product	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N050802-001	6387383	2020-08-03	U-916	Drug product	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N050802-001	6387383	2020-08-03	U-916	Drug product	`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
ZIANA	CLINDAMYCIN PHOSPHATE AND TRETINOIN	Bausch Health US, LLC	78c329f9-f0c9-486d-9e54-0123699fb9e1	2026-05-15	Warnings, Adverse reactions	Exact identifier application applno (NDA): 050802 application number: NDA050802 ndc (product): 99207-300
Clindamycin Phosphate 1.2% and Tretinoin 0.025%	CLINDAMYCIN PHOSPHATE AND TRETINOIN	Oceanside Pharmaceuticals	63b2e85d-8fe5-4f18-9e85-8492c49a7520	2020-04-01	Warnings, Adverse reactions	Exact identifier application applno (NDA): 050802 application number: NDA050802 ndc (product): 68682-300

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
68682-300	Clindamycin Phosphate 1.2% and Tretinoin 0.025%	clindamycin phosphate and tretinoin	Oceanside Pharmaceuticals	NDA AUTHORIZED GENERIC	Current
99207-300	ZIANA	clindamycin phosphate and tretinoin	Medicis Pharmaceutical Corp	NDA	Current
99207-300	ZIANA	clindamycin phosphate and tretinoin	Bausch Health US, LLC	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
42746	ORIG	2008-11-25
30590	ORIG	2006-11-13
18285	ORIG	2006-11-09