dockets: FDA-2012-P-1259
Data license: Public Domain (U.S. Government data) · Data source: Federal Register API & Regulations.gov API
This data as json
| id | agency_id | title | docket_type | last_modified | object_id | rin | dkabstract | category | subtype | keywords | program | short_title | effective_date | organization | attrs_raw | attr_source |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| FDA-2012-P-1259 | FDA | Declare That the Drug Product Pemetrexed Disodium for Injection, 750 mg/vial is Suitable for Submission in an Abbreviated New Drug Application (ANDA) - (Closed) | Nonrulemaking | 2016-09-23T12:23:11Z | 0b0000648119d602 | Docket Status: Closed by email from S. Bacote to DDM Inbox on 9/23/2016 9:34AM | ["cder", "pemetrexed disodium", "ANDA", "750 mg/vial", "ALIMTA", "NDA No. 021462", "orange book", "injection", "2012-10136", "open", "CLOSED"] | CDER | Request FDA declare that the drug product Pemetrexed Disodium for Injection, 750 mg/vial is suitable for submission in an Abbreviated New Drug Application ("ANDA") | {"displayProperties": [{"name": "abstract", "label": "General Information", "tooltip": "Describes an agency's specific regulatory action; equivalents: Abstract, Description, Docket Subject, Related To, Summary."}, {"name": "legacyId", "label": "Legacy ID", "tooltip": "A pre-FDMS agency specific identifier migrated from a legacy system."}, {"name": "generic", "label": "Docket Item Code", "tooltip": "An agency specific code that identifies the type of document that established the docket (regulatory action)."}, {"name": "program", "label": "Center", "tooltip": "The agency specific program associated with the docket (regulatory action); equivalents: Docket Item Code, Location."}, {"name": "field2", "label": "Docket Status", "tooltip": "Used to Identity that a Docket's Status is Open or Closed"}, {"name": "shortTitle", "label": "Short Title", "tooltip": "A combination of letters and or numbers assigned to an agency's regulatory action for purposes of brevity."}], "keywords": ["cder", "pemetrexed disodium", "ANDA", "750 mg/vial", "ALIMTA", "NDA No. 021462", "orange book", "injection", "2012-10136", "open", "CLOSED"], "modifyDate": "2016-09-23T12:23:11Z", "dkAbstract": "Docket Status: Closed by email from S. Bacote to DDM Inbox on 9/23/2016 9:34AM", "agencyId": "FDA", "program": "CDER", "shortTitle": "Request FDA declare that the drug product Pemetrexed Disodium for Injection, 750 mg/vial is suitable for submission in an Abbreviated New Drug Application (\"ANDA\")", "subType2": null, "title": "Declare That the Drug Product Pemetrexed Disodium for Injection, 750 mg/vial is Suitable for Submission in an Abbreviated New Drug Application (ANDA) - (Closed)", "generic": "P", "field1": null, "docketType": "Nonrulemaking", "petitionNbr": null, "rin": null, "organization": null, "legacyId": "2012-10136", "subType": null, "category": null, "field2": "Closed", "effectiveDate": null, "objectId": "0b0000648119d602"} | single_get |
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