Application 205410
- Type
- NDA
- Sponsor
- PIERRE FABRE DERMA
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | HEMANGEOL | PROPRANOLOL HYDROCHLORIDE | SOLUTION;ORAL | 4.28MG/ML | Yes | Yes |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 64370-375 | HEMANGEOL | propranolol hydrochloride | Pierre Fabre Pharmaceuticals, Inc. | NDA | Current |
| 64370-375 | HEMANGEOL | propranolol hydrochloride | Pierre Fabre Pharmaceuticals, Inc. | NDA | Current |
| 64370-375 | HEMANGEOL | propranolol hydrochloride | Pierre Fabre Pharmaceuticals, Inc. | NDA | Current |
| 64370-375 | HEMANGEOL | propranolol hydrochloride | Pierre Fabre Pharmaceuticals, Inc. | NDA | Current |
| 64370-375 | HEMANGEOL | propranolol hydrochloride | Pierre Fabre Pharmaceuticals, Inc. | NDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 69572 | SUPPL | 2021-12-15 |
| 67982 | SUPPL | 2021-06-30 |
| 67887 | SUPPL | 2021-06-24 |
| 62543 | SUPPL | 2020-04-10 |
| 62427 | SUPPL | 2020-04-03 |
| 61391 | SUPPL | 2019-12-23 |
| 61347 | SUPPL | 2019-12-19 |
| 43487 | ORIG | 2015-03-31 |
| 19643 | ORIG | 2014-03-19 |
| 10444 | ORIG | 2014-03-19 |