Application 062832

Type: ANDA
Sponsor: SOCORRO

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	NYSTATIN	NYSTATIN	SUSPENSION;ORAL	100,000 UNITS/ML	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
A062832-001	NYSTATIN	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL	AA		1991-12-27

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A062832-001	AA

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	A062832-001	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL	AA	1991-12-27	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A062832-001	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL	AA	1991-12-27	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A062832-001	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL	AA	1991-12-27	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A062832-001	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL		1991-12-27	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A062832-001	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL		1991-12-27	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A062832-001	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL		1991-12-27	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A062832-001	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL		1991-12-27	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A062832-001	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL		1991-12-27	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A062832-001	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL	AA	1991-12-27	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A062832-001	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL		1991-12-27	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A062832-001	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL		1991-12-27	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A062832-001	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL	AA	1991-12-27	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A062832-001	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL	AA	1991-12-27	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A062832-001	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL	AA	1991-12-27	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A062832-001	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL	AA	1991-12-27	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A062832-001	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL	AA	1991-12-27	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A062832-001	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL	AA	1991-12-27	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A062832-001	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL	AA	1991-12-27	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A062832-001	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL		1991-12-27	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A062832-001	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL	AA	1991-12-27	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A062832-001	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL	AA	1991-12-27	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A062832-001	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL	AA	1991-12-27	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A062832-001	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL	AA	1991-12-27	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A062832-001	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL	AA	1991-12-27	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A062832-001	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL	AA	1991-12-27	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A062832-001	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL		1991-12-27	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A062832-001	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL		1991-12-27	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A062832-001	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL		1991-12-27	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A062832-001	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL	AA	1991-12-27	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A062832-001	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL	AA	1991-12-27	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A062832-001	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL	AA	1991-12-27	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A062832-001	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL	AA	1991-12-27	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A062832-001	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL	AA	1991-12-27	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A062832-001	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL	AA	1991-12-27	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A062832-001	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL	AA	1991-12-27	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A062832-001	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL	AA	1991-12-27	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A062832-001	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL	AA	1991-12-27	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A062832-001	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL	AA	1991-12-27	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A062832-001	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL	AA	1991-12-27	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A062832-001	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL	AA	1991-12-27	`e64feba35796…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A062832-001	AA	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A062832-001	AA	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A062832-001	AA	1	`31067a03dcf5…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A062832-001	AA	1	`5bbf6a4d5a75…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A062832-001	AA	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A062832-001	AA	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A062832-001	AA	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A062832-001	AA	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A062832-001	AA	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A062832-001	AA	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A062832-001	AA	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A062832-001	AA	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A062832-001	AA	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A062832-001	AA	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A062832-001	AA	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A062832-001	AA	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A062832-001	AA	1	`c0c555d07b60…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A062832-001	AA	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A062832-001	AA	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A062832-001	AA	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A062832-001	AA	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A062832-001	AA	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A062832-001	AA	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A062832-001	AA	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A062832-001	AA	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A062832-001	AA	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A062832-001	AA	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A062832-001	AA	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A062832-001	AA	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A062832-001	AA	1	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A062832-001	AA	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 · 5 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
NYSTATIN	NYSTATIN	Kesin Pharma Corporation	50737729-a4a4-e747-e063-6394a90adcc5	2026-06-30	Adverse reactions	Exact identifier application applno (ANDA): 062832 application number: ANDA062832
NYSTATIN	NYSTATIN	Bryant Ranch Prepack	4f6f59fb-ae7d-48e5-b23e-a1d92160974f	2026-05-11	Adverse reactions	Exact identifier application applno (ANDA): 062832 application number: ANDA062832
NYSTATIN	NYSTATIN	Kesin Pharma Corporation	43817169-bbe8-58ee-e063-6294a90a1250	2025-12-11	Adverse reactions	Exact identifier application applno (ANDA): 062832 application number: ANDA062832
NYSTATIN	NYSTATIN	Kanchan Healthcare Inc	90a52c3f-3ef7-4f3b-9fe5-40af408e9f2a	2025-09-12	Adverse reactions	Exact identifier application applno (ANDA): 062832 application number: ANDA062832
NYSTATIN	NYSTATIN	Bryant Ranch Prepack	b06c65cd-5b65-4bc6-aae9-b9381c6f1948	2023-01-26	Adverse reactions	Exact identifier application applno (ANDA): 062832 application number: ANDA062832 ndc (product): 63629-8520

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 12 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
63629-2492	NYSTATIN	NYSTATIN	Bryant Ranch Prepack	ANDA	Current
63629-2492	NYSTATIN	NYSTATIN	Bryant Ranch Prepack	ANDA	Current
63629-2492	NYSTATIN	NYSTATIN	Bryant Ranch Prepack	ANDA	Current
63629-2492	NYSTATIN	NYSTATIN	Bryant Ranch Prepack	ANDA	Current
63629-2493	NYSTATIN	NYSTATIN	Bryant Ranch Prepack	ANDA	Current
63629-2493	NYSTATIN	NYSTATIN	Bryant Ranch Prepack	ANDA	Current
63629-2493	NYSTATIN	NYSTATIN	Bryant Ranch Prepack	ANDA	Current
63629-2493	NYSTATIN	NYSTATIN	Bryant Ranch Prepack	ANDA	Current
63629-8520	NYSTATIN	NYSTATIN	Bryant Ranch Prepack	ANDA	Current
63629-8520	NYSTATIN	NYSTATIN	Bryant Ranch Prepack	ANDA	Current
75834-235	NYSTATIN	NYSTATIN	Nivagen Pharmaceuticals, Inc.	ANDA	Current
75834-235	NYSTATIN	NYSTATIN	Nivagen Pharmaceuticals, Inc.	ANDA	Current