Details for New Drug Application (NDA): 080873
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NDA 080873 describes DIPHENHYDRAMINE HYDROCHLORIDE PRESERVATIVE FREE, which is a drug marketed by Abraxis Pharm, Dr Reddys, Fresenius Kabi Usa, and Intl Medication, and is included in four NDAs. It is available from one supplier. Additional details are available on the DIPHENHYDRAMINE HYDROCHLORIDE PRESERVATIVE FREE profile page.
The generic ingredient in DIPHENHYDRAMINE HYDROCHLORIDE PRESERVATIVE FREE is diphenhydramine hydrochloride. There are twenty-three drug master file entries for this compound. Fourteen suppliers are listed for this compound. Additional details are available on the diphenhydramine hydrochloride profile page.
The generic ingredient in DIPHENHYDRAMINE HYDROCHLORIDE PRESERVATIVE FREE is diphenhydramine hydrochloride. There are twenty-three drug master file entries for this compound. Fourteen suppliers are listed for this compound. Additional details are available on the diphenhydramine hydrochloride profile page.
Summary for 080873
| Tradename: | DIPHENHYDRAMINE HYDROCHLORIDE PRESERVATIVE FREE |
| Applicant: | Dr Reddys |
| Ingredient: | diphenhydramine hydrochloride |
| Patents: | 0 |
Medical Subject Heading (MeSH) Categories for 080873
Profile for product number 001
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | INJECTABLE;INJECTION | Strength | 10MG/ML | ||||
| Approval Date: | Approved Prior to Jan 1, 1982 | TE: | RLD: | No | |||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | INJECTABLE;INJECTION | Strength | 50MG/ML | ||||
| Approval Date: | Approved Prior to Jan 1, 1982 | TE: | RLD: | No | |||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | INJECTABLE;INJECTION | Strength | 50MG/ML | ||||
| Approval Date: | Approved Prior to Jan 1, 1982 | TE: | RLD: | No | |||||
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