Application 088237
- Type
- ANDA
- Sponsor
- XSPIRE PHARMA
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | DEXAMETHASONE | DEXAMETHASONE | TABLET;ORAL | 1.5MG | No | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 10544-211 | Dexamethasone | dexamethasone | Blenheim Pharmacal, Inc. | ANDA | Current |
| 15014-211 | HiDex 6-day | dexamethasone | Gentex Pharma | ANDA | Current |
| 15014-211 | HiDex 6-day | dexamethasone | Gentex Pharma, Llc | ANDA | Current |
| 42195-121 | TaperDex 6-day | DEXAMETHASONE | Xspire Pharma, Llc | ANDA | Current |
| 42195-121 | TaperDex 6-day | DEXAMETHASONE | Xspire Pharma, Llc | ANDA | Current |
| 42195-121 | TaperDex 6-day | DEXAMETHASONE | Xspire Pharma, Llc | ANDA | Current |
| 42195-127 | TaperDex 7-day | dexamethasone | Xspire Pharma, Llc | ANDA | Current |
| 42195-127 | TaperDex 7-day | dexamethasone | Xspire Pharma, Llc | ANDA | Current |
| 42195-127 | TaperDex 7-day | dexamethasone | Xspire Pharma, Llc | ANDA | Current |
| 42195-127 | TaperDex 7-day | dexamethasone | Xspire Pharma, Llc | ANDA | Current |
| 42195-149 | TaperDex 12-day | DEXAMETHASONE | Xspire Pharma, Llc | ANDA | Current |
| 42195-149 | TaperDex 12-day | DEXAMETHASONE | Xspire Pharma, Llc | ANDA | Current |
| 42195-149 | TaperDex 12-day | DEXAMETHASONE | Xspire Pharma, Llc | ANDA | Current |
| 42195-151 | Dexamethasone | DEXAMETHASONE | Xspire Pharma, LLC | ANDA | Current |
| 42195-151 | Dexamethasone | DEXAMETHASONE | Xspire Pharma, LLC | ANDA | Current |
| 42195-221 | TaperDex 6-day | DEXAMETHASONE | Xspire Pharma, Llc | ANDA | Current |
| 42195-221 | TaperDex 6-day | DEXAMETHASONE | Xspire Pharma, Llc | ANDA | Current |
| 42195-221 | TaperDex 6-day | DEXAMETHASONE | Xspire Pharma, Llc | ANDA | Current |
| 42195-270 | TaperDex 7-day | dexamethasone | Xspire Pharma, Llc | ANDA | Current |
| 42195-270 | TaperDex 7-day | dexamethasone | Xspire Pharma, Llc | ANDA | Current |
| 42195-490 | TaperDex 12-day | DEXAMETHASONE | Xspire Pharma, Llc | ANDA | Current |
| 42195-490 | TaperDex 12-day | DEXAMETHASONE | Xspire Pharma, Llc | ANDA | Current |
| 42195-721 | DEXAMETHASONE 6-Day | DEXAMETHASONE | Xspire Pharma, Llc | ANDA | Current |
| 42195-721 | DEXAMETHASONE 6-Day | DEXAMETHASONE | Xspire Pharma, Llc | ANDA | Current |
| 49884-086 | Dexamethasone | dexamethasone | Par Pharmaceutical Inc. | ANDA | Current |
| 49884-086 | Dexamethasone | dexamethasone | Par Pharmaceutical Inc. | ANDA | Current |
| 55700-854 | TaperDex 6-day | DEXAMETHASONE | Quality Care Products, LLC | ANDA | Current |
| 61919-269 | Dexamethasone | Dexamethasone | Direct Rx | ANDA | Current |
| 61919-269 | Dexamethasone | Dexamethasone | Direct Rx | ANDA | Current |
| 61919-269 | Dexamethasone | Dexamethasone | Direct Rx | ANDA | Current |
| 61919-269 | Dexamethasone | Dexamethasone | Direct Rx | ANDA | Current |
| 71205-012 | TaperDex 6-day | DEXAMETHASONE | Proficient Rx LP | ANDA | Current |
| 71205-012 | TaperDex 6-day | DEXAMETHASONE | Proficient Rx LP | ANDA | Current |
| 71205-012 | TaperDex 6-day | DEXAMETHASONE | Proficient Rx LP | ANDA | Current |
| 71205-013 | TaperDex 12-day | DEXAMETHASONE | Proficient Rx LP | ANDA | Current |
| 71205-013 | TaperDex 12-day | DEXAMETHASONE | Proficient Rx LP | ANDA | Current |