Details for New Drug Application (NDA): 203550
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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 203550
Tradename: | METHOCARBAMOL |
Applicant: | Dbl Pharms |
Ingredient: | methocarbamol |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 203550
Physiological Effect | Centrally-mediated Muscle Relaxation |
Medical Subject Heading (MeSH) Categories for 203550
Suppliers and Packaging for NDA: 203550
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
METHOCARBAMOL | methocarbamol | TABLET;ORAL | 203550 | ANDA | NCS HealthCare of KY, LLC dba Vangard Labs | 0615-8435 | 0615-8435-39 | 30 TABLET, FILM COATED in 1 BLISTER PACK (0615-8435-39) |
METHOCARBAMOL | methocarbamol | TABLET;ORAL | 203550 | ANDA | NCS HealthCare of KY, LLC dba Vangard Labs | 0615-8436 | 0615-8436-39 | 30 TABLET, FILM COATED in 1 BLISTER PACK (0615-8436-39) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 500MG | ||||
Approval Date: | Feb 8, 2017 | TE: | AA | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 750MG | ||||
Approval Date: | Feb 8, 2017 | TE: | AA | RLD: | No |
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