Details for New Drug Application (NDA): 019268
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The generic ingredient in CYTOTEC is misoprostol. There are fourteen drug master file entries for this compound. Sixteen suppliers are listed for this compound. Additional details are available on the misoprostol profile page.
Summary for 019268
Tradename: | CYTOTEC |
Applicant: | Pfizer |
Ingredient: | misoprostol |
Patents: | 0 |
Suppliers and Packaging for NDA: 019268
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
CYTOTEC | misoprostol | TABLET;ORAL | 019268 | NDA | Pfizer Laboratories Div Pfizer Inc | 0025-1451 | 0025-1451-34 | 100 BLISTER PACK in 1 CARTON (0025-1451-34) / 1 TABLET in 1 BLISTER PACK |
CYTOTEC | misoprostol | TABLET;ORAL | 019268 | NDA | Pfizer Laboratories Div Pfizer Inc | 0025-1451 | 0025-1451-60 | 60 TABLET in 1 BOTTLE, UNIT-DOSE (0025-1451-60) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 0.2MG | ||||
Approval Date: | Dec 27, 1988 | TE: | AB | RLD: | Yes |
Profile for product number 003
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 0.1MG | ||||
Approval Date: | Sep 21, 1990 | TE: | AB | RLD: | Yes |
Expired US Patents for NDA 019268
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Pfizer | CYTOTEC | misoprostol | TABLET;ORAL | 019268-003 | Sep 21, 1990 | ⤷ Sign Up | ⤷ Sign Up |
Pfizer | CYTOTEC | misoprostol | TABLET;ORAL | 019268-001 | Dec 27, 1988 | ⤷ Sign Up | ⤷ Sign Up |
Pfizer | CYTOTEC | misoprostol | TABLET;ORAL | 019268-001 | Dec 27, 1988 | ⤷ Sign Up | ⤷ Sign Up |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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