Application 090633

Type: ANDA
Sponsor: GLENMARK PHARMS INC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	CALCIPOTRIENE	CALCIPOTRIENE	OINTMENT;TOPICAL	0.005%	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
A090633-001	CALCIPOTRIENE	CALCIPOTRIENE	0.005%	OINTMENT / TOPICAL	AB	RS	2010-03-24

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A090633-001	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	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A090633-001	CALCIPOTRIENE	0.005%	OINTMENT / TOPICAL	AB	RS	2010-03-24	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090633-001	CALCIPOTRIENE	0.005%	OINTMENT / TOPICAL	AB	RS	2010-03-24	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090633-001	CALCIPOTRIENE	0.005%	OINTMENT / TOPICAL	AB	RS	2010-03-24	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090633-001	CALCIPOTRIENE	0.005%	OINTMENT / TOPICAL	AB	RS	2010-03-24	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090633-001	CALCIPOTRIENE	0.005%	OINTMENT / TOPICAL	AB	RS	2010-03-24	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090633-001	CALCIPOTRIENE	0.005%	OINTMENT / TOPICAL	AB	RS	2010-03-24	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090633-001	CALCIPOTRIENE	0.005%	OINTMENT / TOPICAL	AB	RS	2010-03-24	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090633-001	CALCIPOTRIENE	0.005%	OINTMENT / TOPICAL	AB	RS	2010-03-24	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090633-001	CALCIPOTRIENE	0.005%	OINTMENT / TOPICAL	AB	RS	2010-03-24	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A090633-001	CALCIPOTRIENE	0.005%	OINTMENT / TOPICAL	AB	RS	2010-03-24	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090633-001	CALCIPOTRIENE	0.005%	OINTMENT / TOPICAL	AB	RS	2010-03-24	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090633-001	CALCIPOTRIENE	0.005%	OINTMENT / TOPICAL	AB	RS	2010-03-24	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090633-001	CALCIPOTRIENE	0.005%	OINTMENT / TOPICAL	AB	RS	2010-03-24	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A090633-001	CALCIPOTRIENE	0.005%	OINTMENT / TOPICAL	AB	RS	2010-03-24	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090633-001	CALCIPOTRIENE	0.005%	OINTMENT / TOPICAL		RS	2010-03-24	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A090633-001	CALCIPOTRIENE	0.005%	OINTMENT / TOPICAL		RS	2010-03-24	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A090633-001	CALCIPOTRIENE	0.005%	OINTMENT / TOPICAL		RS	2010-03-24	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A090633-001	CALCIPOTRIENE	0.005%	OINTMENT / TOPICAL		RS	2010-03-24	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A090633-001	CALCIPOTRIENE	0.005%	OINTMENT / TOPICAL		RS	2010-03-24	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A090633-001	CALCIPOTRIENE	0.005%	OINTMENT / TOPICAL		RS	2010-03-24	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A090633-001	CALCIPOTRIENE	0.005%	OINTMENT / TOPICAL		RS	2010-03-24	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A090633-001	CALCIPOTRIENE	0.005%	OINTMENT / TOPICAL		RS	2010-03-24	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A090633-001	CALCIPOTRIENE	0.005%	OINTMENT / TOPICAL		RS	2010-03-24	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A090633-001	CALCIPOTRIENE	0.005%	OINTMENT / TOPICAL		RS	2010-03-24	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A090633-001	CALCIPOTRIENE	0.005%	OINTMENT / TOPICAL		RS	2010-03-24	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A090633-001	CALCIPOTRIENE	0.005%	OINTMENT / TOPICAL		RS	2010-03-24	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A090633-001	CALCIPOTRIENE	0.005%	OINTMENT / TOPICAL		RS	2010-03-24	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A090633-001	CALCIPOTRIENE	0.005%	OINTMENT / TOPICAL	AB	RS	2010-03-24	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A090633-001	CALCIPOTRIENE	0.005%	OINTMENT / TOPICAL	AB	RS	2010-03-24	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A090633-001	CALCIPOTRIENE	0.005%	OINTMENT / TOPICAL	AB	RS	2010-03-24	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A090633-001	CALCIPOTRIENE	0.005%	OINTMENT / TOPICAL	AB	RS	2010-03-24	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A090633-001	CALCIPOTRIENE	0.005%	OINTMENT / TOPICAL	AB	RS	2010-03-24	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A090633-001	CALCIPOTRIENE	0.005%	OINTMENT / TOPICAL	AB	RS	2010-03-24	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A090633-001	CALCIPOTRIENE	0.005%	OINTMENT / TOPICAL	AB	RS	2010-03-24	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A090633-001	CALCIPOTRIENE	0.005%	OINTMENT / TOPICAL	AB	RS	2010-03-24	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A090633-001	CALCIPOTRIENE	0.005%	OINTMENT / TOPICAL	AB	RS	2010-03-24	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A090633-001	CALCIPOTRIENE	0.005%	OINTMENT / TOPICAL	AB	RS	2010-03-24	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A090633-001	CALCIPOTRIENE	0.005%	OINTMENT / TOPICAL	AB	RS	2010-03-24	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A090633-001	CALCIPOTRIENE	0.005%	OINTMENT / TOPICAL		RS	2010-03-24	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A090633-001	CALCIPOTRIENE	0.005%	OINTMENT / TOPICAL		RS	2010-03-24	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A090633-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090633-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090633-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090633-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090633-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090633-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090633-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090633-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090633-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A090633-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090633-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090633-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090633-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A090633-001	AB	1	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A090633-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A090633-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A090633-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A090633-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A090633-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A090633-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A090633-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A090633-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A090633-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A090633-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A090633-001	AB	1	`f41ea6bd6efb…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A090633-001	AB	1	`a50c72e98297…`

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 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Calcipotriene	CALCIPOTRIENE	Sun Pharmaceutical Industries, Inc.	277d843a-0ea9-429d-813d-49ed72dafb64	2026-07-14	Adverse reactions	Exact identifier application applno (ANDA): 090633 application number: ANDA090633 ndc (product): 51672-4154
Calcitrene	CALCIPOTRIENE	Sun Pharmaceutical Industries, Inc.	94d4f46a-f254-4fe2-b4bd-7a533d6324fe	2026-07-14	Adverse reactions	Exact identifier application applno (ANDA): 090633 application number: ANDA090633 ndc (product): 51672-5278
Calcipotriene	CALCIPOTRIENE	Glenmark Pharmaceuticals Inc., USA	1bc020e0-b5ae-4cda-aa5b-87fa0452a6bc	2026-01-23	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090633 application number: ANDA090633 ndc (product): 68462-310

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 10 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
51407-606	Calcipotriene	Calcipotriene	Golden State Medical Supply, Inc.	ANDA	Current
51407-606	Calcipotriene	Calcipotriene	Golden State Medical Supply, Inc.	ANDA	Current
51672-4154	Calcipotriene	Calcipotriene	Taro Pharmaceuticals U.S.A., Inc.	ANDA	Current
51672-4154	Calcipotriene	Calcipotriene	Taro Pharmaceuticals U.S.A., Inc.	ANDA	Current
51672-5278	Calcitrene	Calcipotriene	Taro Pharmaceuticals U.S.A., Inc.	ANDA	Current
68462-310	Calcipotriene	Calcipotriene	Glenmark Pharmaceuticals Inc., USA	ANDA	Current
68462-310	Calcipotriene	Calcipotriene	Glenmark Pharmaceuticals Inc., USA	ANDA	Current
68462-310	Calcipotriene	Calcipotriene	Glenmark Pharmaceuticals Inc., USA	ANDA	Current
68462-310	Calcipotriene	Calcipotriene	Glenmark Pharmaceuticals Inc., USA	ANDA	Current
68462-831	KALOSAR	Calcipotriene	Glenmark Pharmaceuticals Inc., USA	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
43241	ORIG	2012-11-16
31481	ORIG	2010-03-29