PROPRANOLOL HYDROCHLORIDE | N019536 | WYETH AYERST LABORATORIES
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Attachment 2 - Prescribing Information for INDERAL (propranolol) Tablets RE S... FDA-2023-P-4320 Lachman Consultant Services, Inc. filed a petition regarding the prescribing information for INDERAL (propranolol) tablets, which appears to relate to the suitability or acceptability of the product's labeling and regulatory documentation. The specific requested action involves review and potential | Suitability | 2023-10-03 | Open | Lachman Consultant Services |
Attachment 1 - FDA Orange Book page for INDERAL (propranolol) Tablets RE Suit... FDA-2023-P-4320 Lachman Consultant Services, Inc. filed a petition regarding the suitability of INDERAL (propranolol) tablets, as documented in the FDA Orange Book. The petition addresses regulatory considerations related to the approved drug product listing and its Orange Book designation. | Suitability | 2023-10-03 | Open | Lachman Consultant Services |
Source: Regulations.gov. FDA citizen petitions matched by application number.
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