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TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN
ANDA · Abbreviated New Drug Application (Generic) · Sponsor: MICRO LABS LTD INDIA · Approved 2012-12-14
Drug application
- FDA Application #
ANDA201952
- Application type
- Abbreviated New Drug Application (Generic)
- Brand name
- TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN
- Generic name
- TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN
- Active ingredients
- ACETAMINOPHEN; TRAMADOL HYDROCHLORIDE
- Dosage form
- TABLET
- Route
- ORAL
- Marketing status
- Prescription
- Sponsor
- MICRO LABS LTD INDIA
- Manufacturer
- Micro Labs Limited
- First approval
- 2012-12-14
Source
- Authoritative
- Drugs@FDA application overview
- Machine
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