Details for New Drug Application (NDA): 208677
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The generic ingredient in PREGABALIN is pregabalin. There are forty-one drug master file entries for this compound. Fifty-six suppliers are listed for this compound. Additional details are available on the pregabalin profile page.
Summary for 208677
Tradename: | PREGABALIN |
Applicant: | Sciegen Pharms Inc |
Ingredient: | pregabalin |
Patents: | 0 |
Medical Subject Heading (MeSH) Categories for 208677
Suppliers and Packaging for NDA: 208677
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
PREGABALIN | pregabalin | CAPSULE;ORAL | 208677 | ANDA | Medsource Pharmaceuticals | 45865-106 | 45865-106-30 | 30 CAPSULE in 1 BOTTLE (45865-106-30) |
PREGABALIN | pregabalin | CAPSULE;ORAL | 208677 | ANDA | Medsource Pharmaceuticals | 45865-107 | 45865-107-30 | 30 CAPSULE in 1 BOTTLE (45865-107-30) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | 25MG | ||||
Approval Date: | Jul 19, 2019 | TE: | AB | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | 50MG | ||||
Approval Date: | Jul 19, 2019 | TE: | AB | RLD: | No |
Profile for product number 003
Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | 75MG | ||||
Approval Date: | Jul 19, 2019 | TE: | AB | RLD: | No |
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