Details for New Drug Application (NDA): 208113
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NDA 208113 describes PREGABALIN, which is a drug marketed by ACI, Acme Labs, Actavis Elizabeth, Adaptis, Alembic, Alkem Labs Ltd, Amneal Pharms Co, Apotex, Aurobindo Pharma, Cadila Pharms Ltd, Changzhou Pharm, Chartwell Rx, Cipla, Creekwood Pharms, Dr Reddys, Hetero Labs Ltd Iii, Invagen Pharms, Lupin Ltd, MSN, Norvium Bioscience, Prinston Inc, Rising, Rk Pharma, Sciegen Pharms Inc, Strides Pharma, Sun Pharm, Teva Pharms, Yiling, Zydus Pharms, Patrin, Alvogen, Epic Pharma Llc, and Rubicon, and is included in forty-five NDAs. It is available from fifty-three suppliers. Additional details are available on the PREGABALIN profile page.
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.
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 208113
| Tradename: | PREGABALIN |
| Applicant: | Adaptis |
| Ingredient: | pregabalin |
| Patents: | 0 |
Medical Subject Heading (MeSH) Categories for 208113
Suppliers and Packaging for NDA: 208113
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| PREGABALIN | pregabalin | CAPSULE;ORAL | 208113 | ANDA | Indoco Remedies Limited | 14445-123 | 14445-123-10 | 100 CAPSULE in 1 BLISTER PACK (14445-123-10) |
| PREGABALIN | pregabalin | CAPSULE;ORAL | 208113 | ANDA | Indoco Remedies Limited | 14445-123 | 14445-123-90 | 90 CAPSULE in 1 BOTTLE (14445-123-90) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | 25MG | ||||
| Approval Date: | May 17, 2024 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | 50MG | ||||
| Approval Date: | May 17, 2024 | TE: | AB | RLD: | No | ||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | 150MG | ||||
| Approval Date: | May 17, 2024 | TE: | AB | RLD: | No | ||||
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