Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 062746
Company: AZURITY
Company: AZURITY
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
ERYTHROMYCIN | ERYTHROMYCIN | 250MG | CAPSULE, DELAYED REL PELLETS;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 |
---|---|---|---|---|---|---|---|
12/22/1986 | ORIG-1 | Approval |
Label is not available on this site. |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
03/10/2022 | SUPPL-14 | Labeling-Package Insert |
Label is not available on this site. |
||
03/10/2022 | SUPPL-12 | Labeling-Package Insert |
Label is not available on this site. |
||
09/28/2009 | SUPPL-10 | Labeling |
Label is not available on this site. |
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07/06/2009 | SUPPL-9 | Labeling |
Label is not available on this site. |
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04/20/1998 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |
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03/17/2004 | SUPPL-5 | Labeling |
Label is not available on this site. |
ERYTHROMYCIN
CAPSULE, DELAYED REL PELLETS;ORAL; 250MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
ERYC | ERYTHROMYCIN | 250MG | CAPSULE, DELAYED REL PELLETS;ORAL | Prescription | Yes | AB | 050536 | DR REDDYS LABS SA |
ERYTHROMYCIN | ERYTHROMYCIN | 250MG | CAPSULE, DELAYED REL PELLETS;ORAL | Prescription | No | AB | 062746 | AZURITY |