Details for New Drug Application (NDA): 064082
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NDA 064082 describes AMPICILLIN TRIHYDRATE, which is a drug marketed by Aurobindo Pharma, Belcher Pharms, Chartwell Rx, Ivax Sub Teva Pharms, Lederle, Mylan, Purepac Pharm, Sandoz, Strides Pharma, Vitarine, Endo Operations, and Teva, and is included in sixteen NDAs. It is available from three suppliers. Additional details are available on the AMPICILLIN TRIHYDRATE profile page.
The generic ingredient in AMPICILLIN TRIHYDRATE is ampicillin/ampicillin trihydrate. Three suppliers are listed for this compound. Additional details are available on the ampicillin/ampicillin trihydrate profile page.
The generic ingredient in AMPICILLIN TRIHYDRATE is ampicillin/ampicillin trihydrate. Three suppliers are listed for this compound. Additional details are available on the ampicillin/ampicillin trihydrate profile page.
Summary for 064082
| Tradename: | AMPICILLIN TRIHYDRATE |
| Applicant: | Sandoz |
| Ingredient: | ampicillin/ampicillin trihydrate |
| Patents: | 0 |
Suppliers and Packaging for NDA: 064082
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| AMPICILLIN TRIHYDRATE | ampicillin/ampicillin trihydrate | CAPSULE;ORAL | 064082 | ANDA | Sandoz Inc | 0781-2144 | 0781-2144-01 | 100 CAPSULE in 1 BOTTLE (0781-2144-01) |
| AMPICILLIN TRIHYDRATE | ampicillin/ampicillin trihydrate | CAPSULE;ORAL | 064082 | ANDA | Sandoz Inc | 0781-2144 | 0781-2144-05 | 500 CAPSULE in 1 BOTTLE (0781-2144-05) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | CAPSULE;ORAL | Strength | EQ 250MG BASE | ||||
| Approval Date: | Aug 29, 1995 | TE: | RLD: | No | |||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | EQ 500MG BASE | ||||
| Approval Date: | Aug 29, 1995 | TE: | AB | RLD: | No | ||||
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