Application 062512

Type: ANDA
Sponsor: WOCKHARDT BIO AG

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	Yes

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
A062512-001	NYSTATIN	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL	AA		1984-10-29

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A062512-001	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	RLD / RS	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A062512-001	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL	AA		1984-10-29	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A062512-001	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL	AA		1984-10-29	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A062512-001	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL	AA		1984-10-29	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A062512-001	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL	AA		1984-10-29	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A062512-001	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL	AA		1984-10-29	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A062512-001	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL	AA		1984-10-29	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A062512-001	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL	AA		1984-10-29	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A062512-001	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL	AA		1984-10-29	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A062512-001	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL	AA		1984-10-29	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A062512-001	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL	AA		1984-10-29	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A062512-001	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL	AA		1984-10-29	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A062512-001	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL	AA		1984-10-29	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A062512-001	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL	AA	RS	1984-10-29	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A062512-001	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL	AA	RS	1984-10-29	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A062512-001	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL	AA	RS	1984-10-29	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A062512-001	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL	AA	RS	1984-10-29	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A062512-001	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL	AA	RS	1984-10-29	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A062512-001	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL	AA	RS	1984-10-29	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A062512-001	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL	AA	RS	1984-10-29	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A062512-001	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL	AA	RS	1984-10-29	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A062512-001	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL	AA	RS	1984-10-29	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A062512-001	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL	AA	RS	1984-10-29	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A062512-001	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL	AA	RS	1984-10-29	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A062512-001	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL	AA	RS	1984-10-29	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A062512-001	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL	AA	RS	1984-10-29	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A062512-001	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL	AA	RS	1984-10-29	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A062512-001	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL	AA	RS	1984-10-29	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A062512-001	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL	AA	RS	1984-10-29	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A062512-001	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL	AA	RS	1984-10-29	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A062512-001	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL	AA	RS	1984-10-29	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A062512-001	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL	AA	RS	1984-10-29	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A062512-001	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL	AA	RS	1984-10-29	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A062512-001	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL	AA	RS	1984-10-29	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A062512-001	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL	AA	RS	1984-10-29	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A062512-001	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL	AA	RS	1984-10-29	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A062512-001	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL	AA	RS	1984-10-29	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A062512-001	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL	AA	RS	1984-10-29	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A062512-001	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL	AA	RS	1984-10-29	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A062512-001	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL	AA	RS	1984-10-29	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A062512-001	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL	AA	RS	1984-10-29	`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	A062512-001	AA	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A062512-001	AA	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A062512-001	AA	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A062512-001	AA	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A062512-001	AA	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A062512-001	AA	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A062512-001	AA	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A062512-001	AA	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A062512-001	AA	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A062512-001	AA	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A062512-001	AA	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A062512-001	AA	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A062512-001	AA	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A062512-001	AA	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A062512-001	AA	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A062512-001	AA	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A062512-001	AA	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A062512-001	AA	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A062512-001	AA	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A062512-001	AA	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A062512-001	AA	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A062512-001	AA	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A062512-001	AA	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A062512-001	AA	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A062512-001	AA	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A062512-001	AA	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A062512-001	AA	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A062512-001	AA	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A062512-001	AA	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A062512-001	AA	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A062512-001	AA	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A062512-001	AA	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A062512-001	AA	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A062512-001	AA	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A062512-001	AA	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A062512-001	AA	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A062512-001	AA	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A062512-001	AA	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A062512-001	AA	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A062512-001	AA	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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Nystatin Oral Suspension	NYSTATIN	Xttrium Laboratories, Inc.	4a670371-d373-1ba6-e063-6394a90a13b6	2026-02-06	Adverse reactions	Exact identifier application applno (ANDA): 062512 application number: ANDA062512
Nystatin	NYSTATIN	A-S Medication Solutions	e069d495-7f1a-4970-8f4d-aa93d124b3fc	2023-02-04	Adverse reactions	Exact identifier application applno (ANDA): 062512 application number: ANDA062512 ndc (product): 50090-1740

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 21 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0121-4785	Nystatin	Nystatin	Pharmaceutical Associates, Inc.	ANDA	Current
17856-0037	Nystatin	Nystatin	ATLANTIC BIOLOGICALS CORP.	ANDA	Current
17856-0538	Nystatin	Nystatin	ATLANTIC BIOLOGICALS CORP.	ANDA	Current
42254-067	Nystatin	Nystatin	Rebel Distributors Corp	ANDA	Current
50090-1740	Nystatin	nystatin	A-S Medication Solutions	ANDA	Current
55154-1578	Nystatin	Nystatin	Cardinal Health 107, LLC	ANDA	Current
55154-1578	Nystatin	Nystatin	Cardinal Health	ANDA	Current
55154-1578	Nystatin	Nystatin	Cardinal Health	ANDA	Current
55154-1578	Nystatin	Nystatin	Cardinal Health	ANDA	Current
60432-537	Nystatin	nystatin	Morton Grove Pharmaceuticals, Inc.	ANDA	Current
63629-2598	Nystatin	Nystatin	Bryant Ranch Prepack	ANDA	Current
63739-634	Nystatin	Nystatin	McKesson Corporation	ANDA	Current
63739-634	Nystatin	nystatin	McKesson Corporation dba SKY Packaging	ANDA	Current
68094-599	Nystatin	Nystatin	Precision Dose, Inc.	ANDA	Current
68094-599	Nystatin	Nystatin	Precision Dose, Inc.	ANDA	Current
68094-599	Nystatin	Nystatin	Precision Dose, Inc.	ANDA	Current
68094-599	Nystatin	Nystatin	Precision Dose, Inc.	ANDA	Current
68788-6792	Nystatin	Nystatin	Preferred Pharmaceuticals, Inc.	ANDA	Current
68788-6792	Nystatin	Nystatin	Preferred Pharmaceuticals, Inc.	ANDA	Current
68788-6792	Nystatin	Nystatin	Preferred Pharmaceuticals, Inc.	ANDA	Current
68788-6792	Nystatin	Nystatin	Preferred Pharmaceuticals, Inc.	ANDA	Current