Details for New Drug Application (NDA): 018337
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NDA 018337 describes INFANTS' FEVERALL, which is a drug marketed by Taro and is included in one NDA. It is available from one supplier. Additional details are available on the INFANTS' FEVERALL profile page.
The generic ingredient in INFANTS' FEVERALL is acetaminophen. There are sixty-six drug master file entries for this compound. Ninety-four suppliers are listed for this compound. Additional details are available on the acetaminophen profile page.
The generic ingredient in INFANTS' FEVERALL is acetaminophen. There are sixty-six drug master file entries for this compound. Ninety-four suppliers are listed for this compound. Additional details are available on the acetaminophen profile page.
Summary for 018337
| Tradename: | INFANTS' FEVERALL |
| Applicant: | Taro |
| Ingredient: | acetaminophen |
| Patents: | 0 |
Medical Subject Heading (MeSH) Categories for 018337
Suppliers and Packaging for NDA: 018337
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| ACETAMINOPHEN | acetaminophen | SUPPOSITORY;RECTAL | 018337 | NDA | Sun Pharmaceutical Industries, Inc. | 51672-2114 | 51672-2114-2 | 6 BLISTER PACK in 1 CARTON (51672-2114-2) / 1 SUPPOSITORY in 1 BLISTER PACK (51672-2114-0) |
| ACETAMINOPHEN | acetaminophen | SUPPOSITORY;RECTAL | 018337 | NDA | Sun Pharmaceutical Industries, Inc. | 51672-2114 | 51672-2114-4 | 50 BLISTER PACK in 1 CARTON (51672-2114-4) / 1 SUPPOSITORY in 1 BLISTER PACK (51672-2114-0) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | SUPPOSITORY;RECTAL | Strength | 650MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ||||
| Approval Date: | Approved Prior to Jan 1, 1982 | TE: | RLD: | Yes | |||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | OTC | Dosage: | SUPPOSITORY;RECTAL | Strength | 325MG | ||||
| Approval Date: | Approved Prior to Jan 1, 1982 | TE: | RLD: | Yes | |||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | OTC | Dosage: | SUPPOSITORY;RECTAL | Strength | 120MG | ||||
| Approval Date: | Sep 12, 1983 | TE: | RLD: | Yes | |||||
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