Application 075774
- Type
- ANDA
- Sponsor
- PERRIGO ISRAEL
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | AMMONIUM LACTATE | AMMONIUM LACTATE | CREAM;TOPICAL | EQ 12% BASE | No | Yes |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 45802-493 | Ammonium Lactate | Ammonium Lactate | Padagis Israel Pharmaceuticals Ltd | ANDA | Current |
| 45802-493 | Ammonium Lactate | Ammonium Lactate | Perrigo New York Inc | ANDA | Current |
| 63629-8608 | Ammonium Lactate | Ammonium Lactate | Bryant Ranch Prepack | ANDA | Current |
| 63629-8608 | Ammonium Lactate | Ammonium Lactate | Bryant Ranch Prepack | ANDA | Current |
| 63629-8608 | Ammonium Lactate | Ammonium Lactate | Bryant Ranch Prepack | ANDA | Current |
| 63629-8609 | Ammonium Lactate | Ammonium Lactate | Bryant Ranch Prepack | ANDA | Current |
| 63629-8609 | Ammonium Lactate | Ammonium Lactate | Bryant Ranch Prepack | ANDA | Current |
| 63629-8609 | Ammonium Lactate | Ammonium Lactate | Bryant Ranch Prepack | ANDA | Current |
| 70518-2449 | Ammonium Lactate | Ammonium Lactate | REMEDYREPACK INC. | ANDA | Current |
| 70518-2449 | Ammonium Lactate | Ammonium Lactate | REMEDYREPACK INC. | ANDA | Current |
| 70518-2449 | Ammonium Lactate | Ammonium Lactate | REMEDYREPACK INC. | ANDA | Current |
| 70518-2449 | Ammonium Lactate | Ammonium Lactate | REMEDYREPACK INC. | ANDA | Current |
| 70518-2449 | Ammonium Lactate | Ammonium Lactate | REMEDYREPACK INC. | ANDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 22501 | ORIG | 2005-07-22 |