ATROPINE SULFATE | N021146 | HOSPIRA INC
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Attachment 4 Draft Guidance on Atropine Sulfate re Suitability Petition from ... FDA-2023-P-4550 · 8 docket documents Pharmobedient Consulting LLC filed a petition regarding atropine sulfate seeking FDA guidance on the suitability of the drug substance for use in pharmaceutical formulations. The petition requests clarification on regulatory pathways and acceptance criteria for atropine sulfate submissions under app | Suitability | 2023-10-17 | Denied | Pharmobedient Consulting LLC |
Citizen Petition from Lachman Consultants FDA-2019-P-2123 · 4 docket documents Lachman Consultants filed this citizen petition on behalf of a client requesting that the FDA determine whether Atropine Sulfate Ansyr Plastic Syringe (0.5mg/5mL), NDA 021146, held by Hospira Inc., was voluntarily withdrawn from the commercial market for safety or effectiveness reasons under 21 CFR | 505(q) | 2019-05-02 | Granted | Lachman Consultants |
Citizen Petition from ZYDUS Pharmaceuticals FDA-2014-P-2142 · 3 docket documents Zydus Pharmaceuticals (USA) Inc. filed this citizen petition under Section 505(j)(2)(C) of the Federal Food, Drug, and Cosmetic Act, requesting that the FDA declare Atropine Sulfate Injection USP, 0.4 mg/mL in a 20 mL multidose vial suitable for submission as an abbreviated new drug application (AND | Other | 2014-12-09 | Withdrawn | ZYDUS Pharmaceuticals |
Citizen Petition from Gordon Johnston Regulatory Consultants LLC FDA-2014-P-1670 · 5 docket documents Gordon Johnston Regulatory Consultants LLC filed this citizen petition under Section 505(j)(2)(C) requesting that the FDA declare Atropine Sulfate Injection USP, 0.4 mg/ml, 20 ml multiple-dose vial suitable for submission in an abbreviated new drug application (ANDA), with the reference-listed drug | Other | 2014-10-21 | Open | Gordon Johnston Regulatory Consultants LLC |
Sheppard, Mullin, Richter & Hampton LLP - Citizen Petition FDA-2012-P-0986 · 11 docket documents Sheppard Mullin, Richter & Hampton LLP filed this citizen petition on behalf of an unnamed petitioner under Section 505(j)(2)(C) of the Federal Food, Drug, and Cosmetic Act requesting that the FDA declare Atropine Sulfate Injection, USP 1.0 mg/mL in a 1 mL glass vial suitable for submission via an A | Other | 2012-09-26 | Open | — |
Sheppard, Mullin, Richter & Hampton LLP - Citizen Petition FDA-2012-P-0993 · 3 docket documents Sheppard Mullin Richter & Hampton LLP filed this ANDA suitability petition under Section 505(j)(2)(C) of the Federal Food, Drug, and Cosmetic Act requesting that the FDA declare Atropine Sulfate Injection, USP 1.0 mg/ml in a 1 ml glass ampule suitable for ANDA submission, with Hospira's Atropine Sul | Other | 2012-09-26 | Withdrawn | — |
Citizens Petition from Lachman Consultant Services, Inc. FDA-2005-P-0134 · 5 docket documents Lachman Consultant Services, Inc. filed this petition on behalf of a client under Section 505(j)(2)(C) of the Federal Food, Drug and Cosmetic Act requesting that the FDA declare Diphenoxylate Hydrochloride and Atropine Sulfate Oral Solution USP at a strength of 5 mg/0.05 mg per 5 mL suitable for sub | Other | 2008-12-24 | Denied | Lachman Consultant Services, Inc. |
Citizens Petition from Lachman Consultant Services, Inc. FDA-2005-P-0381 · 5 docket documents Lachman Consultant Services, Inc. filed this petition on April 25, 2005, requesting that the FDA declare Diphenoxylate Hydrochloride and Atropine Sulfate Tablets USP 5 mg/0.05 mg suitable for submission as an ANDA based on the reference listed drug Lomotil Tablets 2.5 mg/0.025 mg. The petition seeks | Other | 2008-12-24 | Denied | Lachman Consultant Services, Inc. |
Source: Regulations.gov. FDA citizen petitions matched by application number.
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