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Application 021359
- Type
- NDA
- Sponsor
- ALLERGAN
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | RECTIV | NITROGLYCERIN | OINTMENT;INTRA-ANAL | 0.4% | Yes | Yes |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 42747-235 | Rectiv | nitroglycerin | ProStrakan, Inc. | NDA | Current |
| 58914-301 | Rectiv | nitroglycerin | Allergan, Inc. | NDA | Current |
| 58914-301 | Rectiv | nitroglycerin | Allergan, Inc. | NDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 79293 | SUPPL | 2024-08-02 |
| 79292 | SUPPL | 2024-08-02 |
| 24193 | ORIG | 2012-02-29 |
| 21616 | ORIG | 2012-02-29 |
| 15286 | ORIG | 2011-06-30 |
| 27583 | ORIG | 2011-06-29 |