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FDA Approval Activities for this Drug…

Zithromax TRI-PAK (azithromycin) Tablets, 500 mg, Pfizer NDA 50-784/S2 10/16/02 10/21/02 Zithromax TRI-PAK (azithromycin) Tablets, 500 mg, Pfizer NDA 50-784 5/24/02 6/3/02 10/22/02 10/22/02 Zithromax (Azithromycin) Suspension, Pfizer NDA 50-710/S-016 6/20/03 7/6/03 Zithromax (AzithromycinDihydrate) Capsules, Single Dose Packet, Suspension, Tablets & IV, 250 & 600 (Mac) mg tablets, Pfizer NDA 50-670/S19, 50-693/S7, 50-710/S-014, 50-711/S-012, 50-733/S-010 & 50-730/S10 7/22/02 7/24/02 Zithromax (Azithromycin) Capsules, Single Dose Packet & Tablets, Pfizer NDA 50-670/S17, 50-693/S5 & 50-730/S7 10/16/02 10/21/02 Zithromax (Azithromycin) Capsules, Single Dose Packet & Tablets Pfizer NDA 50-670/S15, 50-693/S3 & 50-730/S5 11/13/00 11/9/01 Zithromax (azithromycin tablets) Pfizer, NDA 50-710/S8 12/14/01 5/2/03 Zithromax (azithromycin tablets) Pfizer, NDA 50-710/S9 12/14/01 5/2/03 Zithromax (azithromycin for injection), I.V., Pfizer, NDA 50-733/S-05 2/28/01 5/2/03 Zithromax (azithromycin for injection), I.V., Pfizer, NDA 50-733/S-009 3/13/02 3/29/02 Zithromax (azithromycin for injection), I.V., Pfizer, NDA 50-733/S-007 6/12/03 7/8/03 Zithromax (azithromycin for injection), I.V., Pfizer, NDA 50-733/S-006 10/16/02 10/21/02 Zithromax (azithromycin) Suspension and Tablets, Pfizer NDA 50-710/S7 & 50-711/S8 10/16/02 10/21/02 Zithromax (azithromycin) Pediatric Suspension, and Zithromax (azithromycin)Tablets, Pfizer NDA 50-710/S11 & 50-711/S9 5/24/02 6/3/02 5/28/02 Zithromax (azithromycin) for Suspension, Pfizer, NDA 50-710/S-008/S-009 AZITHROMYCIN Capsule; 250MG BASE ZITHROMAX PFIZER 050710 AZITHROMYCIN For Suspension; 100MG BASE/5ML ZITHROMAX PFIZER 050693 AZITHROMYCIN For Suspension; 1GM BASE/PACKET ZITHROMAX PFIZER 050710 AZITHROMYCIN For Suspension; 200MG BASE/5ML ZITHROMAX PFIZER 050711 AZITHROMYCIN Tablet; 250MG BASE ZITHROMAX PFIZER 050784 AZITHROMYCIN Tablet; 500MG BASE ZITHROMAX PFIZER 050730 AZITHROMYCIN Tablet; 600MG BASE ZITHROMAX PFIZER 050733 AZITHROMYCIN DIHYDRATE Injection 500MG BASE/VIAL ZITHROMAX PFIZER Zithromax (azithromycin) Oral Suspension & Tablets, Pfizer Inc. Zithromax (azithromycin) Injection, Pfizer, Inc. Zithromax (Azithromycin) Capsules, Single Dose Packet &Tablets, Pfizer Inc. Zithromax (azithromycin) Tablets, Pfizer Inc. Zithromax (azithromycin) Oral Suspension & Tablets, Pfizer Inc. Zithromax (Azithromycin) Capsules, Single Dose Packet &Tablets, Pfizer Inc. Zithromax (azithromycin) Oral Suspension, Pfizer Inc.

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