Nystatin Topical Powder
- Brand(s)
- Nyamyc, Nystop
- Category(s)
- prescription
- SPL Type(s)
- Human Prescription
- Master SPL
- Mayne Pharma Inc. (2009-08-31)
- Oldest Current Product
- 1996-08-16
- License(s)
- ANDA
- RxNORM
- TOPICAL POWDER\NYSTATIN
- FDAOB
- TOPICAL\POWDER\NYSTATIN
- SPL Active
- CUTANEOUS\POWDER\NYSTATIN
TOPICAL\POWDER\NYSTATIN - SPL Moiety
- CUTANEOUS\POWDER\NYSTATIN
TOPICAL\POWDER\NYSTATIN
product(s) by strength(s)
nystatin 100 unt/mg topical powder
generic product(s)(s)
| # | id | brand | category | labeler | first marketed | active ingredient(s) | route | dose form | application | spl |
|---|---|---|---|---|---|---|---|---|---|---|
| 1 | 005742008 | Nystop | ANDA | Paddock Laboratories, Llc | 1996-08-16 | NYSTATIN | TOPICAL | POWDER | ANDA064118 | e1b4622c-0f9f-4c00-b42c-2aa85a5e3d4f |
| 2 | 008320465 | Nyamyc | ANDA | Upsher-Smith Laboratories, Inc. | 2005-05-03 | NYSTATIN | CUTANEOUS | POWDER | ANDA065183 | 01b44f91-9b68-464a-9693-b5d3e793bf3c |
| 3 | 009046456 | ANDA | Major | 2015-02-15 | NYSTATIN | TOPICAL | POWDER | ANDA065138 | ce5a8256-ff1b-45eb-b1cf-c863cdff97c5 | |
| 4 | 398223015 | ANDA | X-Gen Pharmaceuticals, Inc. | 2004-08-30 | NYSTATIN | TOPICAL | POWDER | ANDA065175 | a6f88015-4cac-4cb2-9012-92cc5390b5df | |
| 5 | 425430052 | ANDA | Vensun Pharmaceuticals, Inc. | 2014-09-01 | NYSTATIN | TOPICAL | POWDER | ANDA065175 | f64aacd0-4d8b-4a21-bfcb-8eb183bc6d86 | |
| 6 | 433860530 | ANDA | Gavis Pharmaceuticals, Llc | 2014-09-26 | NYSTATIN | TOPICAL | POWDER | ANDA065138 | cf863efe-53d7-4654-94fc-6530ecdff921 | |
| 7 | 683080152 | ANDA | Mayne Pharma Inc. | 2004-07-15 | NYSTATIN | TOPICAL | POWDER | ANDA065203 | 656fc23b-65af-465e-9bcb-67fbbfa9b84e |
relabeler product(s)(s)
| # | id | category | labeler | first marketed | active ingredient(s) | route | dose form | equivalent product | application | spl |
|---|---|---|---|---|---|---|---|---|---|---|
| 1 | 422540303 | ANDA | Rebel Distributors Corp | 2009-09-15 | NYSTATIN | TOPICAL | POWDER | 683080152 | ANDA065203 | 1211504c-f89b-42ed-9d7a-2e1a658a9ccf |
| 2 | 548685216 | ANDA | Physicians Total Care, Inc. | 2005-01-27 | NYSTATIN | TOPICAL | POWDER | 005742008 | ANDA064118 | d62d9d90-3ef2-4697-b6d5-bdb892394998 |
| 3 | 765191007 | ANDA | H.J. Harkins Company, Inc. | 2009-09-15 | NYSTATIN | TOPICAL | POWDER | 683080152 | ANDA065203 | 9e122c5f-65e4-4c92-aaa0-ae97dd725b1a |
application(s)
| # | id | title | deprecated | applicant | approved | approved drug |
|---|---|---|---|---|---|---|
| 1 | ANDA060578 | MYCOSTATIN | True | DELCOR ASSET CORP | ANDA060578_001 | |
| 2 | ANDA064118 | NYSTOP | PADDOCK LABORATORIES LLC | 1996-08-16 | ANDA064118_001 | |
| 3 | ANDA065138 | NYSTATIN | GAVIS PHARMACEUTICALS LLC | 2004-07-23 | ANDA065138_001 | |
| 4 | ANDA065175 | NYSTATIN | X GEN PHARMACEUTICALS INC | 2004-12-17 | ANDA065175_001 | |
| 5 | ANDA065183 | NYSTATIN | UPSHER SMITH LABORATORIES INC | 2005-05-03 | ANDA065183_001 | |
| 6 | ANDA065203 | NYSTATIN | COASTAL PHARMACEUTICALS | 2004-07-15 | ANDA065203_001 | |
| 7 | ANDA065321 | NYSTATIN | True | NESHER PHARMACEUTICALS USA LLC | 2006-08-18 | ANDA065321_001 |
application drug(s)
| # | id | category/deprecated | ingredient strength(s) | route | dose form | rld | TE | approved | application |
|---|---|---|---|---|---|---|---|---|---|
| 1 | ANDA060578_001 | discontinued | NYSTATIN (100,000 UNITS/GM) | TOPICAL | POWDER | False | MYCOSTATIN | ||
| 2 | ANDA064118_001 | RX | NYSTATIN (100,000 UNITS/GM) | TOPICAL | POWDER | False | AT | 1996-08-16 | NYSTOP |
| 3 | ANDA065138_001 | RX | NYSTATIN (100,000 UNITS/GM) | TOPICAL | POWDER | False | AT | 2004-07-23 | NYSTATIN |
| 4 | ANDA065175_001 | RX | NYSTATIN (100,000 UNITS/GM) | TOPICAL | POWDER | False | AT | 2004-12-17 | NYSTATIN |
| 5 | ANDA065183_001 | RX | NYSTATIN (100,000 UNITS/GM) | TOPICAL | POWDER | False | AT | 2005-05-03 | NYSTATIN |
| 6 | ANDA065203_001 | RX | NYSTATIN (100,000 UNITS/GM) | TOPICAL | POWDER | True | AT | 2004-07-15 | NYSTATIN |
| 7 | ANDA065321_001 | discontinued | NYSTATIN (100,000 UNITS/GM) | TOPICAL | POWDER | False | 2006-08-18 | NYSTATIN |
spl(s)
| # | id | title | category | type | labeler | labeler act | last update | version | product(s) |
|---|---|---|---|---|---|---|---|---|---|
| 1 | 01b44f91-9b68-464a-9693-b5d3e793bf3c (view SPL) | Nyamyc (Nystatin Topical Powder, USP) | prescription | Human Prescription | Upsher-Smith Laboratories, Inc. | 2012-05-04 | 4 | 008320465 | |
| 2 | 1211504c-f89b-42ed-9d7a-2e1a658a9ccf (view SPL) | NYSTATIN TOPICAL POWDER, USP | prescription | Human Prescription | Rebel Distributors Corp | RELABEL, REPACK | 2012-09-26 | 1 | 422540303 |
| 3 | 656fc23b-65af-465e-9bcb-67fbbfa9b84e (view SPL) | NYSTATIN TOPICAL POWDER, USP | prescription | Human Prescription | Mayne Pharma Inc. | MANUFACTURE | 2009-08-31 | 2 | 683080152 |
| 4 | 9e122c5f-65e4-4c92-aaa0-ae97dd725b1a (view SPL) | NYSTATIN TOPICAL POWDER, USP | prescription | Human Prescription | H.J. Harkins Company, Inc. | MANUFACTURE | 2012-10-19 | 1 | 765191007 |
| 5 | a6f88015-4cac-4cb2-9012-92cc5390b5df (view SPL) | Rx Only. FOR TOPICAL USE ONLY.Not for Ophthalmic Use. | prescription | Human Prescription | X-Gen Pharmaceuticals, Inc. | 2014-08-04 | 7 | 398223015 | |
| 6 | ce5a8256-ff1b-45eb-b1cf-c863cdff97c5 (view SPL) | NYSTATIN TOPICAL POWDER, USP | prescription | Human Prescription | Major | 2015-02-13 | 1 | 009046456 | |
| 7 | cf863efe-53d7-4654-94fc-6530ecdff921 (view SPL) | NYSTATIN TOPICAL POWDER, USP | prescription | Human Prescription | Gavis Pharmaceuticals, Llc | ANALYSIS, MANUFACTURE | 2014-09-26 | 1 | 433860530 |
| 8 | d62d9d90-3ef2-4697-b6d5-bdb892394998 (view SPL) | Nystop Nystatin Topical Powder USP | prescription | Human Prescription | Physicians Total Care, Inc. | relabel | 2010-08-25 | 1 | 548685216 |
| 9 | e1b4622c-0f9f-4c00-b42c-2aa85a5e3d4f (view SPL) | Nystop Nystatin Topical Powder, USP Rx Only For topical use only.Not for ophthalmic use. | prescription | Human Prescription | Paddock Laboratories, Llc | MANUFACTURE | 2014-09-17 | 6 | 005742008 |
| 10 | f64aacd0-4d8b-4a21-bfcb-8eb183bc6d86 (view SPL) | Rx Only. FOR TOPICAL USE ONLY.Not for Ophthalmic Use. | prescription | Human Prescription | Vensun Pharmaceuticals, Inc. | MANUFACTURE | 2014-07-31 | 7 | 425430052 |
Data from: FDAOB, FDAPB, LOINC, MTHSPL, NDFRT, NCIT, RxNORM, UNII