Details for New Drug Application (NDA): 213967
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The generic ingredient in METHOCARBAMOL is aspirin; methocarbamol. There are twenty-two drug master file entries for this compound. Additional details are available on the aspirin; methocarbamol profile page.
Summary for 213967
Tradename: | METHOCARBAMOL |
Applicant: | Aurobindo Pharma Ltd |
Ingredient: | methocarbamol |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 213967
Physiological Effect | Centrally-mediated Muscle Relaxation |
Medical Subject Heading (MeSH) Categories for 213967
Suppliers and Packaging for NDA: 213967
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
METHOCARBAMOL | methocarbamol | TABLET;ORAL | 213967 | ANDA | NCS HealthCare of KY, LLC dba Vangard Labs | 0615-8506 | 0615-8506-39 | 30 TABLET, FILM COATED in 1 BLISTER PACK (0615-8506-39) |
METHOCARBAMOL | methocarbamol | TABLET;ORAL | 213967 | ANDA | NCS HealthCare of KY, LLC dba Vangard Labs | 0615-8507 | 0615-8507-39 | 30 TABLET, FILM COATED in 1 BLISTER PACK (0615-8507-39) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 750MG | ||||
Approval Date: | Aug 12, 2020 | TE: | AA | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 500MG | ||||
Approval Date: | Feb 9, 2023 | TE: | AA | RLD: | No |
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