Application 074543
- Type
- ANDA
- Sponsor
- HI TECH PHARMA
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | ALBUTEROL SULFATE | ALBUTEROL SULFATE | SOLUTION;INHALATION | EQ 0.5% BASE | No | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 21695-245 | Albuterol Sulfate | Albuterol Sulfate | Rebel Distributors Corp. | ANDA | Current |
| 50090-0517 | Albuterol Sulfate | Albuterol Sulfate | A-S Medication Solutions | ANDA | Current |
| 50383-741 | Albuterol Sulfate | Albuterol Sulfate | Akorn | ANDA | Current |
| 50383-741 | Albuterol Sulfate | Albuterol Sulfate | Hi-Tech Pharmacal Co., Inc. | ANDA | Current |
| 50383-741 | Albuterol Sulfate | Albuterol Sulfate | Hi-Tech Pharmacal Co., Inc. | ANDA | Current |
| 68788-9782 | Albuterol Sulfate | Albuterol Sulfate | Preferred Pharmaceuticals, Inc. | ANDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 22343 | ORIG | 1998-01-15 |