Application 207163

Type: ANDA
Sponsor: NOVEL LABS INC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	CALCIPOTRIENE	CALCIPOTRIENE	SOLUTION;TOPICAL	0.005%	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
A207163-001	CALCIPOTRIENE	CALCIPOTRIENE	0.005%	SOLUTION / TOPICAL	AT		2017-12-26

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A207163-001	AT

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	A207163-001	CALCIPOTRIENE	0.005%	SOLUTION / TOPICAL	AT	2017-12-26	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207163-001	CALCIPOTRIENE	0.005%	SOLUTION / TOPICAL	AT	2017-12-26	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A207163-001	CALCIPOTRIENE	0.005%	SOLUTION / TOPICAL	AT	2017-12-26	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207163-001	CALCIPOTRIENE	0.005%	SOLUTION / TOPICAL	AT	2017-12-26	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207163-001	CALCIPOTRIENE	0.005%	SOLUTION / TOPICAL	AT	2017-12-26	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207163-001	CALCIPOTRIENE	0.005%	SOLUTION / TOPICAL	AT	2017-12-26	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207163-001	CALCIPOTRIENE	0.005%	SOLUTION / TOPICAL	AT	2017-12-26	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207163-001	CALCIPOTRIENE	0.005%	SOLUTION / TOPICAL	AT	2017-12-26	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207163-001	CALCIPOTRIENE	0.005%	SOLUTION / TOPICAL	AT	2017-12-26	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A207163-001	CALCIPOTRIENE	0.005%	SOLUTION / TOPICAL	AT	2017-12-26	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207163-001	CALCIPOTRIENE	0.005%	SOLUTION / TOPICAL	AT	2017-12-26	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207163-001	CALCIPOTRIENE	0.005%	SOLUTION / TOPICAL	AT	2017-12-26	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A207163-001	CALCIPOTRIENE	0.005%	SOLUTION / TOPICAL	AT	2017-12-26	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A207163-001	CALCIPOTRIENE	0.005%	SOLUTION / TOPICAL	AT	2017-12-26	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A207163-001	CALCIPOTRIENE	0.005%	SOLUTION / TOPICAL	AT	2017-12-26	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A207163-001	CALCIPOTRIENE	0.005%	SOLUTION / TOPICAL	AT	2017-12-26	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A207163-001	CALCIPOTRIENE	0.005%	SOLUTION / TOPICAL	AT	2017-12-26	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A207163-001	CALCIPOTRIENE	0.005%	SOLUTION / TOPICAL	AT	2017-12-26	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A207163-001	CALCIPOTRIENE	0.005%	SOLUTION / TOPICAL	AT	2017-12-26	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A207163-001	CALCIPOTRIENE	0.005%	SOLUTION / TOPICAL	AT	2017-12-26	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A207163-001	CALCIPOTRIENE	0.005%	SOLUTION / TOPICAL	AT	2017-12-26	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A207163-001	CALCIPOTRIENE	0.005%	SOLUTION / TOPICAL	AT	2017-12-26	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A207163-001	CALCIPOTRIENE	0.005%	SOLUTION / TOPICAL	AT	2017-12-26	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A207163-001	CALCIPOTRIENE	0.005%	SOLUTION / TOPICAL	AT	2017-12-26	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A207163-001	CALCIPOTRIENE	0.005%	SOLUTION / TOPICAL	AT	2017-12-26	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A207163-001	CALCIPOTRIENE	0.005%	SOLUTION / TOPICAL	AT	2017-12-26	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A207163-001	CALCIPOTRIENE	0.005%	SOLUTION / TOPICAL	AT	2017-12-26	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A207163-001	CALCIPOTRIENE	0.005%	SOLUTION / TOPICAL	AT	2017-12-26	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A207163-001	CALCIPOTRIENE	0.005%	SOLUTION / TOPICAL	AT	2017-12-26	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A207163-001	CALCIPOTRIENE	0.005%	SOLUTION / TOPICAL	AT	2017-12-26	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A207163-001	CALCIPOTRIENE	0.005%	SOLUTION / TOPICAL	AT	2017-12-26	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A207163-001	CALCIPOTRIENE	0.005%	SOLUTION / TOPICAL	AT	2017-12-26	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A207163-001	CALCIPOTRIENE	0.005%	SOLUTION / TOPICAL	AT	2017-12-26	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A207163-001	CALCIPOTRIENE	0.005%	SOLUTION / TOPICAL	AT	2017-12-26	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A207163-001	CALCIPOTRIENE	0.005%	SOLUTION / TOPICAL	AT	2017-12-26	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A207163-001	CALCIPOTRIENE	0.005%	SOLUTION / TOPICAL	AT	2017-12-26	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A207163-001	CALCIPOTRIENE	0.005%	SOLUTION / TOPICAL	AT	2017-12-26	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A207163-001	CALCIPOTRIENE	0.005%	SOLUTION / TOPICAL	AT	2017-12-26	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A207163-001	CALCIPOTRIENE	0.005%	SOLUTION / TOPICAL	AT	2017-12-26	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A207163-001	CALCIPOTRIENE	0.005%	SOLUTION / TOPICAL	AT	2017-12-26	`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	A207163-001	AT	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207163-001	AT	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A207163-001	AT	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207163-001	AT	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207163-001	AT	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207163-001	AT	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207163-001	AT	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207163-001	AT	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207163-001	AT	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A207163-001	AT	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207163-001	AT	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207163-001	AT	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A207163-001	AT	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A207163-001	AT	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A207163-001	AT	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A207163-001	AT	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A207163-001	AT	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A207163-001	AT	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A207163-001	AT	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A207163-001	AT	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A207163-001	AT	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A207163-001	AT	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A207163-001	AT	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A207163-001	AT	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A207163-001	AT	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A207163-001	AT	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A207163-001	AT	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A207163-001	AT	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A207163-001	AT	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A207163-001	AT	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A207163-001	AT	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A207163-001	AT	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A207163-001	AT	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A207163-001	AT	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A207163-001	AT	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A207163-001	AT	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A207163-001	AT	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A207163-001	AT	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A207163-001	AT	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A207163-001	AT	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 · 11 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	Name fallback brand name: Calcipotriene generic name: CALCIPOTRIENE
Calcitrene	CALCIPOTRIENE	Sun Pharmaceutical Industries, Inc.	94d4f46a-f254-4fe2-b4bd-7a533d6324fe	2026-07-14	Adverse reactions	Name fallback generic name: CALCIPOTRIENE
Pellix	CALCIPOTRIENE	Perfero Pharma, Inc.	492ea9cf-0117-4d84-a964-9c0121706ed3	2026-05-04	Warnings, Adverse reactions	Name fallback generic name: CALCIPOTRIENE
Calcipotriene	CALCIPOTRIENE	Glenmark Pharmaceuticals Inc., USA	1bc020e0-b5ae-4cda-aa5b-87fa0452a6bc	2026-01-23	Warnings, Adverse reactions	Name fallback brand name: Calcipotriene generic name: CALCIPOTRIENE
calcipotriene	CALCIPOTRIENE	Glenmark Pharmaceuticals Inc.,USA	7ec750f6-26ea-46bc-aa7b-174fd25253a2	2025-10-27	Warnings, Adverse reactions	Name fallback brand name: calcipotriene generic name: CALCIPOTRIENE
calcipotriene	CALCIPOTRIENE	Northstar Rx LLC	a882ef4f-603e-4421-97ae-2c78822c767a	2024-06-24	Warnings, Adverse reactions	Name fallback brand name: calcipotriene generic name: CALCIPOTRIENE
calcipotriene	CALCIPOTRIENE	Mayne Pharma	26756ac7-a80c-49db-97bb-351f76ad8a71	2024-05-09	Warnings, Adverse reactions	Name fallback brand name: calcipotriene generic name: CALCIPOTRIENE
SORILUX	CALCIPOTRIENE	Mayne Pharma	51f208d0-7b3f-44cc-8bed-92fa3d2e7bbe	2024-05-09	Warnings, Adverse reactions	Name fallback generic name: CALCIPOTRIENE
Calcipotriene	CALCIPOTRIENE	Prasco Laboratories	377eafda-737c-4ba2-9ec5-61209b8814ed	2022-12-12	Warnings, Adverse reactions	Name fallback brand name: Calcipotriene generic name: CALCIPOTRIENE
Calcipotriene	CALCIPOTRIENE	Cosette Pharmaceuticals, Inc.	21378c25-5622-8bf7-1a8c-b05940a846a0	2022-11-15	Warnings, Adverse reactions	Name fallback brand name: Calcipotriene generic name: CALCIPOTRIENE
calcipotriene	CALCIPOTRIENE	Prasco Laboratories	fe7cd92a-f066-4c4a-80c8-e3f929ad4181	2020-08-07	Warnings, Adverse reactions	Name fallback brand name: calcipotriene generic name: CALCIPOTRIENE

NDC Listings For This Application#

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

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
40032-043	Calcipotriene	Calcipotriene	Novel Laboratories, Inc.	ANDA	Current