Application 020949
- Type
- NDA
- Sponsor
- MYLAN SPECIALITY LP
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | ACCUNEB | ALBUTEROL SULFATE | SOLUTION;INHALATION | EQ 0.042% BASE | Yes | Yes |
| 002 | ACCUNEB | ALBUTEROL SULFATE | SOLUTION;INHALATION | EQ 0.021% BASE | Yes | Yes |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 0378-6991 | Albuterol Sulfate | albuterol sulfate | Mylan Pharmaceuticals Inc. | NDA AUTHORIZED GENERIC | Current |
| 0378-6991 | Albuterol Sulfate | albuterol sulfate | Mylan Pharmaceuticals Inc. | NDA AUTHORIZED GENERIC | Current |
| 0378-6991 | Albuterol Sulfate | albuterol sulfate | Mylan Pharmaceuticals Inc. | NDA AUTHORIZED GENERIC | Current |
| 0378-6991 | Albuterol Sulfate | albuterol sulfate | Mylan Pharmaceuticals Inc. | NDA AUTHORIZED GENERIC | Current |
| 0378-6992 | Albuterol Sulfate | albuterol sulfate | Mylan Pharmaceuticals Inc. | NDA AUTHORIZED GENERIC | Current |
| 0378-6992 | Albuterol Sulfate | albuterol sulfate | Mylan Pharmaceuticals Inc. | NDA AUTHORIZED GENERIC | Current |
| 0378-6992 | Albuterol Sulfate | albuterol sulfate | Mylan Pharmaceuticals Inc. | NDA AUTHORIZED GENERIC | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 70952 | SUPPL | 2022-05-03 |
| 70868 | SUPPL | 2022-05-02 |
| 26283 | SUPPL | 2011-03-07 |
| 13808 | SUPPL | 2011-03-07 |
| 24139 | SUPPL | 2006-06-06 |
| 3836 | SUPPL | 2006-06-06 |
| 41833 | ORIG | 2005-01-28 |