Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 208884
Company: ZYDUS PHARMS
Company: ZYDUS PHARMS
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
ALBUTEROL SULFATE | ALBUTEROL SULFATE | EQ 2MG BASE | TABLET;ORAL | Prescription | AB | No | No |
ALBUTEROL SULFATE | ALBUTEROL SULFATE | EQ 4MG BASE | TABLET;ORAL | Prescription | AB | No | No |
Original Approvals or Tentative Approvals
Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
---|---|---|---|---|---|---|---|
10/22/2020 | ORIG-1 | Approval | STANDARD |
Label is not available on this site. |
ALBUTEROL SULFATE
TABLET;ORAL; EQ 2MG BASE
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
ALBUTEROL SULFATE | ALBUTEROL SULFATE | EQ 2MG BASE | TABLET;ORAL | Prescription | No | AB | 208804 | AMNEAL PHARMS CO |
ALBUTEROL SULFATE | ALBUTEROL SULFATE | EQ 2MG BASE | TABLET;ORAL | Prescription | No | AB | 072894 | DASH PHARMS NATCO |
ALBUTEROL SULFATE | ALBUTEROL SULFATE | EQ 2MG BASE | TABLET;ORAL | Prescription | No | AB | 207046 | RISING |
ALBUTEROL SULFATE | ALBUTEROL SULFATE | EQ 2MG BASE | TABLET;ORAL | Prescription | No | AB | 072637 | SUN PHARM INDUSTRIES |
ALBUTEROL SULFATE | ALBUTEROL SULFATE | EQ 2MG BASE | TABLET;ORAL | Prescription | No | AB | 211397 | VIRTUS PHARM |
ALBUTEROL SULFATE | ALBUTEROL SULFATE | EQ 2MG BASE | TABLET;ORAL | Prescription | No | AB | 208884 | ZYDUS PHARMS |
TABLET;ORAL; EQ 4MG BASE
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
ALBUTEROL SULFATE | ALBUTEROL SULFATE | EQ 4MG BASE | TABLET;ORAL | Prescription | No | AB | 208804 | AMNEAL PHARMS CO |
ALBUTEROL SULFATE | ALBUTEROL SULFATE | EQ 4MG BASE | TABLET;ORAL | Prescription | No | AB | 072894 | DASH PHARMS NATCO |
ALBUTEROL SULFATE | ALBUTEROL SULFATE | EQ 4MG BASE | TABLET;ORAL | Prescription | No | AB | 207046 | RISING |
ALBUTEROL SULFATE | ALBUTEROL SULFATE | EQ 4MG BASE | TABLET;ORAL | Prescription | No | AB | 072637 | SUN PHARM INDUSTRIES |
ALBUTEROL SULFATE | ALBUTEROL SULFATE | EQ 4MG BASE | TABLET;ORAL | Prescription | No | AB | 211397 | VIRTUS PHARM |
ALBUTEROL SULFATE | ALBUTEROL SULFATE | EQ 4MG BASE | TABLET;ORAL | Prescription | No | AB | 208884 | ZYDUS PHARMS |