Details for New Drug Application (NDA): 206752
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NDA 206752 describes PREGABALIN, which is a drug marketed by 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, Eskayef, Hetero Labs Ltd Iii, Hlthcare, Invagen Pharms, Lupin Ltd, Macleods Pharms Ltd, MSN, Norvium Bioscience, Prinston Inc, Renata, Rising, Sciegen Pharms Inc, Strides Pharma, Sun Pharm, Teva Pharms, Torrent, Yiling, Zydus Pharms, Anda Repository, Alvogen, Epic Pharma Llc, Hq Pharma, and Rubicon, and is included in forty-nine NDAs. It is available from fifty-two 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-five 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-five suppliers are listed for this compound. Additional details are available on the pregabalin profile page.
Summary for 206752
| Tradename: | PREGABALIN |
| Applicant: | Zydus Pharms |
| Ingredient: | pregabalin |
| Patents: | 0 |
Medical Subject Heading (MeSH) Categories for 206752
Suppliers and Packaging for NDA: 206752
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| PREGABALIN | pregabalin | CAPSULE;ORAL | 206752 | ANDA | Zydus Pharmaceuticals USA Inc. | 68382-865 | 68382-865-16 | 90 CAPSULE in 1 BOTTLE (68382-865-16) |
| PREGABALIN | pregabalin | CAPSULE;ORAL | 206752 | ANDA | Zydus Pharmaceuticals USA Inc. | 68382-865 | 68382-865-77 | 10 BLISTER PACK in 1 CARTON (68382-865-77) / 10 CAPSULE in 1 BLISTER PACK (68382-865-30) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | CAPSULE;ORAL | Strength | 25MG | ||||
| Approval Date: | Dec 9, 2022 | TE: | RLD: | No | |||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | CAPSULE;ORAL | Strength | 50MG | ||||
| Approval Date: | Dec 9, 2022 | TE: | RLD: | No | |||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | CAPSULE;ORAL | Strength | 75MG | ||||
| Approval Date: | Dec 9, 2022 | TE: | RLD: | No | |||||
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