ISOTRETINOIN | A076135 | TEVA PHARMACEUTICALS USA
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Suitability Petition AMENDMENT from Morgan Lewis & Bockius LLP FDA-2014-P-1282 Morgan Lewis & Bockius LLP filed an amendment to a suitability petition (Docket No. FDA-2014-P-1282) originally submitted July 17, 2014, seeking permission to file an ANDA for Isotretinoin Capsules in 15 mg, 25 mg, and 35 mg strengths. The petitioner provided complete proposed product labeling for t | Suitability | 2016-10-25 | Open | — |
Source: Regulations.gov. FDA citizen petitions matched by application number.
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