Drugs@FDA: FDA Approved Drug Products

Home | Previous Page

Abbreviated New Drug Application (ANDA): 061837
Company: WATSON LABS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
TETRACYCLINE HYDROCHLORIDE TETRACYCLINE HYDROCHLORIDE 250MG CAPSULE;ORAL Prescription AB No No
TETRACYCLINE HYDROCHLORIDE TETRACYCLINE HYDROCHLORIDE 500MG CAPSULE;ORAL Prescription AB No No
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
12/24/1974 ORIG-1 Approval

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
05/20/2002 SUPPL-24 Manufacturing (CMC)-Control

Label is not available on this site.

12/21/1999 SUPPL-23 Manufacturing (CMC)-Facility

Label is not available on this site.

11/10/1999 SUPPL-22 Manufacturing (CMC)-Control

Label is not available on this site.

11/10/1999 SUPPL-21 Manufacturing (CMC)-Facility

Label is not available on this site.

10/01/1999 SUPPL-20 Manufacturing (CMC)

Label is not available on this site.

10/01/1999 SUPPL-19 Manufacturing (CMC)

Label is not available on this site.

05/20/1999 SUPPL-18 Manufacturing (CMC)

Label is not available on this site.

12/01/1998 SUPPL-17 Manufacturing (CMC)

Label is not available on this site.

07/30/1998 SUPPL-16 Manufacturing (CMC)

Label is not available on this site.

10/10/1997 SUPPL-15 Manufacturing (CMC)

Label is not available on this site.

05/08/1996 SUPPL-14 Manufacturing (CMC)

Label is not available on this site.

12/23/1994 SUPPL-13 Manufacturing (CMC)

Label is not available on this site.

10/11/1994 SUPPL-12 Manufacturing (CMC)

Label is not available on this site.

04/03/1992 SUPPL-11 Manufacturing (CMC)

Label is not available on this site.

04/03/1992 SUPPL-9 Manufacturing (CMC)

Label is not available on this site.

10/16/1991 SUPPL-8 Labeling

Label is not available on this site.

02/14/1989 SUPPL-7 Manufacturing (CMC)

Label is not available on this site.

TETRACYCLINE HYDROCHLORIDE

CAPSULE;ORAL; 250MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
ACHROMYCIN V TETRACYCLINE HYDROCHLORIDE 250MG CAPSULE;ORAL Prescription Yes AB 050278 HERITAGE PHARMS INC
TETRACYCLINE HYDROCHLORIDE TETRACYCLINE HYDROCHLORIDE 250MG CAPSULE;ORAL Prescription No AB 210674 AMNEAL PHARMS NY
TETRACYCLINE HYDROCHLORIDE TETRACYCLINE HYDROCHLORIDE 250MG CAPSULE;ORAL Prescription No AB 210662 BRECKENRIDGE
TETRACYCLINE HYDROCHLORIDE TETRACYCLINE HYDROCHLORIDE 250MG CAPSULE;ORAL Prescription No AB 062752 CHARTWELL TETRA
TETRACYCLINE HYDROCHLORIDE TETRACYCLINE HYDROCHLORIDE 250MG CAPSULE;ORAL Prescription No AB 061837 WATSON LABS

CAPSULE;ORAL; 500MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
ACHROMYCIN V TETRACYCLINE HYDROCHLORIDE 500MG CAPSULE;ORAL Prescription Yes AB 050278 HERITAGE PHARMS INC
TETRACYCLINE HYDROCHLORIDE TETRACYCLINE HYDROCHLORIDE 500MG CAPSULE;ORAL Prescription No AB 210674 AMNEAL PHARMS NY
TETRACYCLINE HYDROCHLORIDE TETRACYCLINE HYDROCHLORIDE 500MG CAPSULE;ORAL Prescription No AB 210662 BRECKENRIDGE
TETRACYCLINE HYDROCHLORIDE TETRACYCLINE HYDROCHLORIDE 500MG CAPSULE;ORAL Prescription No AB 062752 CHARTWELL TETRA
TETRACYCLINE HYDROCHLORIDE TETRACYCLINE HYDROCHLORIDE 500MG CAPSULE;ORAL Prescription No AB 061837 WATSON LABS

Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English