Details for New Drug Application (NDA): 087953
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NDA 087953 describes PROMETHAZINE PLAIN, which is a drug marketed by Xttrium Labs Inc and is included in one NDA. It is available from three suppliers. Additional details are available on the PROMETHAZINE PLAIN profile page.
The generic ingredient in PROMETHAZINE PLAIN is promethazine hydrochloride. There are twelve drug master file entries for this compound. Forty-seven suppliers are listed for this compound. Additional details are available on the promethazine hydrochloride profile page.
The generic ingredient in PROMETHAZINE PLAIN is promethazine hydrochloride. There are twelve drug master file entries for this compound. Forty-seven suppliers are listed for this compound. Additional details are available on the promethazine hydrochloride profile page.
Summary for 087953
| Tradename: | PROMETHAZINE PLAIN |
| Applicant: | Xttrium Labs Inc |
| Ingredient: | promethazine hydrochloride |
| Patents: | 0 |
Suppliers and Packaging for NDA: 087953
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| PROMETHAZINE PLAIN | promethazine hydrochloride | SYRUP;ORAL | 087953 | ANDA | Xttrium Laboratories, Inc. | 0116-4023 | 0116-4023-16 | 473 mL in 1 BOTTLE, PLASTIC (0116-4023-16) |
| PROMETHAZINE PLAIN | promethazine hydrochloride | SYRUP;ORAL | 087953 | ANDA | ATLANTIC BIOLOGICALS CORP. | 17856-0608 | 17856-0608-5 | 5 mL in 1 CUP (17856-0608-5) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | SYRUP;ORAL | Strength | 6.25MG/5ML | ||||
| Approval Date: | Nov 15, 1982 | TE: | AA | RLD: | Yes | ||||
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