Application 207767

Type: ANDA
Sponsor: CADILA

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	NYSTATIN	NYSTATIN	OINTMENT;TOPICAL	100,000 UNITS/GM	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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
A207767-001	NYSTATIN	NYSTATIN	100,000 UNITS/GM	OINTMENT / TOPICAL	AT		2018-05-25

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A207767-001	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 · 42 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
2026-08-18 06:07:40	2026-07	A207767-001	NYSTATIN	100,000 UNITS/GM	OINTMENT / TOPICAL	AT	2018-05-25	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A207767-001	NYSTATIN	100,000 UNITS/GM	OINTMENT / TOPICAL	AT	2018-05-25	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207767-001	NYSTATIN	100,000 UNITS/GM	OINTMENT / TOPICAL	AT	2018-05-25	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A207767-001	NYSTATIN	100,000 UNITS/GM	OINTMENT / TOPICAL	AT	2018-05-25	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207767-001	NYSTATIN	100,000 UNITS/GM	OINTMENT / TOPICAL	AT	2018-05-25	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207767-001	NYSTATIN	100,000 UNITS/GM	OINTMENT / TOPICAL	AT	2018-05-25	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207767-001	NYSTATIN	100,000 UNITS/GM	OINTMENT / TOPICAL	AT	2018-05-25	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207767-001	NYSTATIN	100,000 UNITS/GM	OINTMENT / TOPICAL	AT	2018-05-25	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207767-001	NYSTATIN	100,000 UNITS/GM	OINTMENT / TOPICAL	AT	2018-05-25	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207767-001	NYSTATIN	100,000 UNITS/GM	OINTMENT / TOPICAL	AT	2018-05-25	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A207767-001	NYSTATIN	100,000 UNITS/GM	OINTMENT / TOPICAL	AT	2018-05-25	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207767-001	NYSTATIN	100,000 UNITS/GM	OINTMENT / TOPICAL	AT	2018-05-25	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207767-001	NYSTATIN	100,000 UNITS/GM	OINTMENT / TOPICAL	AT	2018-05-25	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A207767-001	NYSTATIN	100,000 UNITS/GM	OINTMENT / TOPICAL	AT	2018-05-25	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A207767-001	NYSTATIN	100,000 UNITS/GM	OINTMENT / TOPICAL	AT	2018-05-25	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A207767-001	NYSTATIN	100,000 UNITS/GM	OINTMENT / TOPICAL	AT	2018-05-25	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A207767-001	NYSTATIN	100,000 UNITS/GM	OINTMENT / TOPICAL	AT	2018-05-25	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A207767-001	NYSTATIN	100,000 UNITS/GM	OINTMENT / TOPICAL	AT	2018-05-25	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A207767-001	NYSTATIN	100,000 UNITS/GM	OINTMENT / TOPICAL	AT	2018-05-25	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A207767-001	NYSTATIN	100,000 UNITS/GM	OINTMENT / TOPICAL	AT	2018-05-25	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A207767-001	NYSTATIN	100,000 UNITS/GM	OINTMENT / TOPICAL	AT	2018-05-25	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A207767-001	NYSTATIN	100,000 UNITS/GM	OINTMENT / TOPICAL	AT	2018-05-25	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A207767-001	NYSTATIN	100,000 UNITS/GM	OINTMENT / TOPICAL	AT	2018-05-25	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A207767-001	NYSTATIN	100,000 UNITS/GM	OINTMENT / TOPICAL	AT	2018-05-25	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A207767-001	NYSTATIN	100,000 UNITS/GM	OINTMENT / TOPICAL	AT	2018-05-25	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A207767-001	NYSTATIN	100,000 UNITS/GM	OINTMENT / TOPICAL	AT	2018-05-25	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A207767-001	NYSTATIN	100,000 UNITS/GM	OINTMENT / TOPICAL	AT	2018-05-25	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A207767-001	NYSTATIN	100,000 UNITS/GM	OINTMENT / TOPICAL	AT	2018-05-25	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A207767-001	NYSTATIN	100,000 UNITS/GM	OINTMENT / TOPICAL	AT	2018-05-25	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A207767-001	NYSTATIN	100,000 UNITS/GM	OINTMENT / TOPICAL	AT	2018-05-25	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A207767-001	NYSTATIN	100,000 UNITS/GM	OINTMENT / TOPICAL	AT	2018-05-25	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A207767-001	NYSTATIN	100,000 UNITS/GM	OINTMENT / TOPICAL	AT	2018-05-25	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A207767-001	NYSTATIN	100,000 UNITS/GM	OINTMENT / TOPICAL	AT	2018-05-25	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A207767-001	NYSTATIN	100,000 UNITS/GM	OINTMENT / TOPICAL	AT	2018-05-25	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A207767-001	NYSTATIN	100,000 UNITS/GM	OINTMENT / TOPICAL	AT	2018-05-25	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A207767-001	NYSTATIN	100,000 UNITS/GM	OINTMENT / TOPICAL	AT	2018-05-25	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A207767-001	NYSTATIN	100,000 UNITS/GM	OINTMENT / TOPICAL	AT	2018-05-25	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A207767-001	NYSTATIN	100,000 UNITS/GM	OINTMENT / TOPICAL	AT	2018-05-25	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A207767-001	NYSTATIN	100,000 UNITS/GM	OINTMENT / TOPICAL	AT	2018-05-25	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A207767-001	NYSTATIN	100,000 UNITS/GM	OINTMENT / TOPICAL	AT	2018-05-25	`e64feba35796…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 42 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A207767-001	AT	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A207767-001	AT	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207767-001	AT	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A207767-001	AT	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207767-001	AT	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207767-001	AT	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207767-001	AT	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207767-001	AT	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207767-001	AT	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207767-001	AT	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A207767-001	AT	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207767-001	AT	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207767-001	AT	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A207767-001	AT	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A207767-001	AT	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A207767-001	AT	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A207767-001	AT	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A207767-001	AT	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A207767-001	AT	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A207767-001	AT	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A207767-001	AT	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A207767-001	AT	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A207767-001	AT	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A207767-001	AT	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A207767-001	AT	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A207767-001	AT	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A207767-001	AT	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A207767-001	AT	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A207767-001	AT	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A207767-001	AT	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A207767-001	AT	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A207767-001	AT	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A207767-001	AT	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A207767-001	AT	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A207767-001	AT	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A207767-001	AT	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A207767-001	AT	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A207767-001	AT	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A207767-001	AT	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A207767-001	AT	1	`e64feba35796…`

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	Zydus Lifesciences Limited	6aa2f67e-9636-45e5-be1b-83e7ab86e436	2024-08-16		Exact identifier application applno (ANDA): 207767 application number: ANDA207767 ndc (product): 70771-1357
Nystatin	NYSTATIN	Bryant Ranch Prepack	93d59122-86f3-489d-9790-1ef6c6aff89d	2024-03-26	Adverse reactions	Exact identifier application applno (ANDA): 207767 application number: ANDA207767
Nystatin	NYSTATIN	A-S Medication Solutions	6a3bb3da-adf9-46d2-a5ff-f796e7aae7a1	2023-11-24	Adverse reactions	Exact identifier application applno (ANDA): 207767 application number: ANDA207767 ndc (product): 50090-5845
Nystatin	NYSTATIN	Bryant Ranch Prepack	53d1c23b-9cf2-4941-8701-8a7da1b066cc	2023-03-03	Adverse reactions	Exact identifier application applno (ANDA): 207767 application number: ANDA207767 ndc (product): 63629-2516
Nystatin	NYSTATIN	Bryant Ranch Prepack	84383bc5-1282-43d6-9303-23c8fd8d075f	2023-03-03	Adverse reactions	Exact identifier application applno (ANDA): 207767 application number: ANDA207767 ndc (product): 63629-2515
Nystatin	NYSTATIN	Viona Pharmaceuticals Inc	e135a7d2-adba-48a2-b3e1-07b778cce9b0	2022-10-08	Adverse reactions	Exact identifier application applno (ANDA): 207767 application number: ANDA207767 ndc (product): 72578-089

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 16 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
50090-5845	Nystatin	Nystatin	A-S Medication Solutions	ANDA	Current
50090-5845	Nystatin	Nystatin	A-S Medication Solutions	ANDA	Current
63629-2515	Nystatin	Nystatin	Bryant Ranch Prepack	ANDA	Current
63629-2515	Nystatin	Nystatin	Bryant Ranch Prepack	ANDA	Current
63629-2516	Nystatin	Nystatin	Bryant Ranch Prepack	ANDA	Current
63629-2516	Nystatin	Nystatin	Bryant Ranch Prepack	ANDA	Current
68382-333	Nystatin	Nystatin	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-333	Nystatin	Nystatin	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-333	Nystatin	Nystatin	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
70771-1357	Nystatin	Nystatin	Cadila Healthcare Limited	ANDA	Current
70771-1357	Nystatin	Nystatin	Cadila Healthcare Limited	ANDA	Current
70771-1357	Nystatin	Nystatin	Zydus Lifesciences Limited	ANDA	Current
70771-1357	Nystatin	Nystatin	Cadila Healthcare Limited	ANDA	Current
72578-089	Nystatin	Nystatin	Viona Pharmaceuticals Inc	ANDA	Current
72578-089	Nystatin	Nystatin	Viona Pharmaceuticals Inc	ANDA	Current
72578-089	Nystatin	Nystatin	Viona Pharmaceuticals Inc	ANDA	Current