Application 212557

Type: ANDA
Sponsor: TORRENT

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	NYSTATIN	NYSTATIN	CREAM;TOPICAL	100,000 UNITS/GM	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
A212557-001	NYSTATIN	NYSTATIN	100,000 UNITS/GM	CREAM / TOPICAL	AT		2019-07-24

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A212557-001	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.

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	A212557-001	NYSTATIN	100,000 UNITS/GM	CREAM / TOPICAL	AT	2019-07-24	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212557-001	NYSTATIN	100,000 UNITS/GM	CREAM / TOPICAL	AT	2019-07-24	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A212557-001	NYSTATIN	100,000 UNITS/GM	CREAM / TOPICAL	AT	2019-07-24	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212557-001	NYSTATIN	100,000 UNITS/GM	CREAM / TOPICAL	AT	2019-07-24	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212557-001	NYSTATIN	100,000 UNITS/GM	CREAM / TOPICAL	AT	2019-07-24	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212557-001	NYSTATIN	100,000 UNITS/GM	CREAM / TOPICAL	AT	2019-07-24	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212557-001	NYSTATIN	100,000 UNITS/GM	CREAM / TOPICAL	AT	2019-07-24	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212557-001	NYSTATIN	100,000 UNITS/GM	CREAM / TOPICAL	AT	2019-07-24	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A212557-001	NYSTATIN	100,000 UNITS/GM	CREAM / TOPICAL	AT	2019-07-24	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A212557-001	NYSTATIN	100,000 UNITS/GM	CREAM / TOPICAL	AT	2019-07-24	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A212557-001	NYSTATIN	100,000 UNITS/GM	CREAM / TOPICAL	AT	2019-07-24	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A212557-001	NYSTATIN	100,000 UNITS/GM	CREAM / TOPICAL	AT	2019-07-24	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A212557-001	NYSTATIN	100,000 UNITS/GM	CREAM / TOPICAL	AT	2019-07-24	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A212557-001	NYSTATIN	100,000 UNITS/GM	CREAM / TOPICAL	AT	2019-07-24	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A212557-001	NYSTATIN	100,000 UNITS/GM	CREAM / TOPICAL	AT	2019-07-24	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A212557-001	NYSTATIN	100,000 UNITS/GM	CREAM / TOPICAL	AT	2019-07-24	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A212557-001	NYSTATIN	100,000 UNITS/GM	CREAM / TOPICAL	AT	2019-07-24	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A212557-001	NYSTATIN	100,000 UNITS/GM	CREAM / TOPICAL	AT	2019-07-24	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A212557-001	NYSTATIN	100,000 UNITS/GM	CREAM / TOPICAL	AT	2019-07-24	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A212557-001	NYSTATIN	100,000 UNITS/GM	CREAM / TOPICAL	AT	2019-07-24	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A212557-001	NYSTATIN	100,000 UNITS/GM	CREAM / TOPICAL	AT	2019-07-24	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A212557-001	NYSTATIN	100,000 UNITS/GM	CREAM / TOPICAL	AT	2019-07-24	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A212557-001	NYSTATIN	100,000 UNITS/GM	CREAM / TOPICAL	AT	2019-07-24	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A212557-001	NYSTATIN	100,000 UNITS/GM	CREAM / TOPICAL	AT	2019-07-24	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A212557-001	NYSTATIN	100,000 UNITS/GM	CREAM / TOPICAL	AT	2019-07-24	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A212557-001	NYSTATIN	100,000 UNITS/GM	CREAM / TOPICAL	AT	2019-07-24	`b00525d2431f…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A212557-001	NYSTATIN	100,000 UNITS/GM	CREAM / TOPICAL	AT	2019-07-24	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A212557-001	NYSTATIN	100,000 UNITS/GM	CREAM / TOPICAL	AT	2019-07-24	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A212557-001	NYSTATIN	100,000 UNITS/GM	CREAM / TOPICAL	AT	2019-07-24	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A212557-001	NYSTATIN	100,000 UNITS/GM	CREAM / TOPICAL	AT	2019-07-24	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A212557-001	NYSTATIN	100,000 UNITS/GM	CREAM / TOPICAL	AT	2019-07-24	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A212557-001	NYSTATIN	100,000 UNITS/GM	CREAM / TOPICAL	AT	2019-07-24	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A212557-001	NYSTATIN	100,000 UNITS/GM	CREAM / TOPICAL	AT	2019-07-24	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A212557-001	NYSTATIN	100,000 UNITS/GM	CREAM / TOPICAL	AT	2019-07-24	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A212557-001	NYSTATIN	100,000 UNITS/GM	CREAM / TOPICAL	AT	2019-07-24	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A212557-001	NYSTATIN	100,000 UNITS/GM	CREAM / TOPICAL	AT	2019-07-24	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A212557-001	NYSTATIN	100,000 UNITS/GM	CREAM / TOPICAL	AT	2019-07-24	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A212557-001	NYSTATIN	100,000 UNITS/GM	CREAM / TOPICAL	AT	2019-07-24	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A212557-001	NYSTATIN	100,000 UNITS/GM	CREAM / TOPICAL	AT	2019-07-24	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A212557-001	NYSTATIN	100,000 UNITS/GM	CREAM / TOPICAL	AT	2019-07-24	`a50c72e98297…`

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	A212557-001	AT	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212557-001	AT	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A212557-001	AT	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212557-001	AT	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212557-001	AT	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212557-001	AT	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212557-001	AT	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212557-001	AT	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A212557-001	AT	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A212557-001	AT	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A212557-001	AT	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A212557-001	AT	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A212557-001	AT	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A212557-001	AT	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A212557-001	AT	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A212557-001	AT	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A212557-001	AT	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A212557-001	AT	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A212557-001	AT	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A212557-001	AT	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A212557-001	AT	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A212557-001	AT	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A212557-001	AT	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A212557-001	AT	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A212557-001	AT	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A212557-001	AT	1	`b00525d2431f…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A212557-001	AT	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A212557-001	AT	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A212557-001	AT	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A212557-001	AT	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A212557-001	AT	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A212557-001	AT	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A212557-001	AT	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A212557-001	AT	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A212557-001	AT	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A212557-001	AT	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A212557-001	AT	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A212557-001	AT	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A212557-001	AT	1	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A212557-001	AT	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 · 6 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Nystatin	NYSTATIN	Preferred Pharmaceuticals Inc.	d92f67a7-dcae-41c0-9a35-dbafa2361170	2026-08-04	Adverse reactions	Exact identifier application applno (ANDA): 212557 application number: ANDA212557
Nystatin	NYSTATIN	Bryant Ranch Prepack	2d2c4f79-95b5-417e-b5c1-8fac1dd09ddc	2026-07-09	Adverse reactions	Exact identifier application applno (ANDA): 212557 application number: ANDA212557
Nystatin	NYSTATIN	Torrent Pharmaceuticals Limited	559b5bd4-3564-4437-8d0a-fa3a972f8b83	2026-05-01	Adverse reactions	Exact identifier application applno (ANDA): 212557 application number: ANDA212557 ndc (product): 13668-595
Nystatin	NYSTATIN	RedPharm Drug, Inc	f4c298d5-b012-7b56-e053-2a95a90a3d55	2026-01-24	Adverse reactions	Exact identifier application applno (ANDA): 212557 application number: ANDA212557
Nystatin	NYSTATIN	A-S Medication Solutions	65167baa-29f8-44d3-b2d2-935c862d463e	2024-10-16	Adverse reactions	Exact identifier application applno (ANDA): 212557 application number: ANDA212557
Nystatin	NYSTATIN	Proficient Rx LP	8566c432-741f-4af7-91d7-1b7668ce5e95	2023-12-01	Adverse reactions	Exact identifier application applno (ANDA): 212557 application number: ANDA212557

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 5 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
13668-595	Nystatin	Nystatin	Torrent Pharmaceuticals Limited	ANDA	Current
13668-595	Nystatin	Nystatin	Torrent Pharmaceuticals Limited	ANDA	Current
13668-595	Nystatin	Nystatin	Torrent Pharmaceuticals Limited	ANDA	Current
68071-2819	Nystatin	Nystatin	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-2887	Nystatin	Nystatin	NuCare Pharmaceuticals,Inc.	ANDA	Current