Details for New Drug Application (NDA): 215249
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NDA 215249 describes PREGABALIN, which is a drug marketed by 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, Anda Repository, 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 215249
| Tradename: | PREGABALIN |
| Applicant: | Rubicon |
| Ingredient: | pregabalin |
| Patents: | 0 |
Medical Subject Heading (MeSH) Categories for 215249
Suppliers and Packaging for NDA: 215249
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| PREGABALIN | pregabalin | TABLET, EXTENDED RELEASE;ORAL | 215249 | ANDA | Advagen Pharma Ltd. | 72888-049 | 72888-049-30 | 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (72888-049-30) |
| PREGABALIN | pregabalin | TABLET, EXTENDED RELEASE;ORAL | 215249 | ANDA | Advagen Pharma Ltd. | 72888-050 | 72888-050-30 | 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (72888-050-30) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, EXTENDED RELEASE;ORAL | Strength | 82.5MG | ||||
| Approval Date: | Mar 22, 2022 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, EXTENDED RELEASE;ORAL | Strength | 165MG | ||||
| Approval Date: | Mar 22, 2022 | TE: | AB | RLD: | No | ||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, EXTENDED RELEASE;ORAL | Strength | 330MG | ||||
| Approval Date: | Mar 22, 2022 | TE: | AB | RLD: | No | ||||
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